	The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC). ADAMS™ A1c HA-8180V (UL) Analyzer - 100675
	ARK Care is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes. ARK Care® - Version 2.5.3.
	ARK Care Advance is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes. ARK Care® Advance Diabetes Management System - Ver 2.0.
	ARK Care VITA is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes. ARK Care® VITA Patient Mobile Application - Ver 1.3.
	A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device. ARKRAY Multi-let 2 Lancing Device - 660016
	Portable Blood Glucose Meter Assure® Platinum BLOOD GLUCOSE METER - 500001
	Blood Glucose Test Strips Assure® Platinum BLOOD GLUCOSE TEST STRIPS - 500010
	Blood Glucose Test Strips Assure® Platinum BLOOD GLUCOSE TEST STRIPS - 500050 500100
	Portable Blood Glucose Meter ASSURE® PRISM MULTI BLOOD GLUCOSE METER - 530001
	Blood Glucose Test Strips ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS - 530050 / 530100
	For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. Assure® Control Level 1 Control Solution (Low) - 510004
	For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. Assure® Control Level 2 Control Solution (Normal) - 510005
	For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. Assure® Control Level 3 Control Solution (High) - 510007
	Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500061 is used as the assigned UDI for the Class I device.) Assure® Dose High (Level 2) Control Solution - 500006
	Assure® Dose High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with CS insert.) Assure® Dose High (Level 2) Control Solution - 502005
	Assure Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500054 is used as the assigned UDI for the Class I device.) Assure® Dose Normal (Level 1) Control Solution - 500005
	Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with logbook and CS insert.) Assure® Dose Normal (Level 1) Control Solution - 502004
	Assure ID DUO PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. Assure® ID DUO PRO Safety Pen Needles 31gx5mm 100's - 277531
	Assure ID DUO PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. Assure® ID DUO PRO Safety Pen Needles 31gx5mm Sample 10's - 277031
	Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100's - 272830
	Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's - 273830
	Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100's - 272530
	Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10's - 273530
	Sterile Safety Syringe ASSURE® ID Insulin 0.5cc Safety Syringe - 210295
	Sterile Safety Syringe ASSURE® ID Insulin 1cc Safety Syringe - 210291
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID INSULIN SAFETY SYRINGE .3mL 29G x 1/2" - 250293
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID INSULIN SAFETY SYRINGE .3mL 31G x 5/16" - 250313
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID INSULIN SAFETY SYRINGE .5mL 31G x 5/16" - 250315
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. Assure® ID INSULIN SAFETY SYRINGE 0.5mL 31G x 6mm - 253315
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID INSULIN SAFETY SYRINGE 1mL 31G x 5/16" - 250311
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. Assure® ID INSULIN SAFETY SYRINGE 1mL 31G x 6mm - 253311
	Assure ID PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks. Assure® ID PRO Safety Pen Needles 30gx5mm 100's - 276530
	Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. Assure® ID Safety Pen Needle 5mm x 30g 100's - 275130
	Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. Assure® ID Safety Pen Needle 5mm x 31g 100's - 275131
	Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. Assure® ID Safety Pen Needle 8mm x 30g 100's - 278130
	Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks. Assure® ID Safety Pen Needles, 30G x 5mm Sample 10's - 275030
	Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks. Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's - 278030
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID Safety Syringe .5mL 29G x 1/2" - 250295
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID Safety Syringe 1mL 29G x 1/2" - 250291
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 1" - 251251
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID TB SAFETY SYRINGE 1mL 25G x 5/8" - 251252
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID TB SAFETY SYRINGE 1mL 27G x 1/2" - 251273
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID TB SAFETY SYRINGE 1mL 28G x 1/2" - 251285
	Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. ASSURE® ID TB SAFETY SYRINGE 1mL 31G x 5/16" - 251316
	Assure Lance Plus Safety Lancets 25g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Plus Safety Lancets - 990125
	Assure Lance Plus Safety Lancets 30g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Plus Safety Lancets - 990130
	Assure Lance Safety Lancets 21g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Safety Lancets - 980121
	Assure Lance Safety Lancets 21g 200's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Safety Lancets - 980225
	Assure Lance Safety Lancets 25g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Safety Lancets - 980125
	Assure Lance Safety Lancets 28g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Safety Lancets - 980128
	Assure Lance Safety Lancets 28g 10's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Safety Lancets - 980028
	Assure Lance Safety Lancets 28g 200's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Safety Lancets - 980228
	Assure Lance Safety Lancets 28g 30ct. Single-use disposable blood lancet should be used for assisted blood drawn by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. Assure® Lance Safety Lancets - 980328
	Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control. Assure® Platinum - 502030
	Assure Platinum Meter Institutional multi-pack (4 Assure Platinum meter kits PN 500001) Assure® Platinum Blood Glucose Meter - 501177
	Blood Glucose Test Strips, Individually Foiled ASSURE® Prism Blood Glucose Test Strips - 532050
	Assure Prism Control Solution contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482530068 is used as the assigned UDI for the Class I device.) Assure® Prism Control Solution - 530006
	Assure Prism Meter Institutional multi-pack (4 Assure Prism meter kits PN 530001) Assure® Prism Multi Blood Glucose Meter - 531177
	Sharps Container for disposal of e.g. needles and syringes (3 Gallon Slide Lid Red) Assure® SD Sharps Container - 243001
	Sharps Container for disposal of e.g. needles and syringes (5 Qt. H Lid Red) Assure® SD Sharps Container - 245001
	Sharps Container for disposal of e.g. needles and syringes (5 Qt. H Lid Translucent) Assure® SD Sharps Container - 245002
	Sharps Container for disposal of e.g. needles and syringes (5 Qt. M Lid Red) Assure® SD Sharps Container - 245003
	Sharps Container for disposal of e.g. needles and syringes (5 Qt. M Lid Translucent) Assure® SD Sharps Container - 245004
	Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100025 is used as the assigned UDI for the Class I device.) Assure® Slide Pill Swallowing Aid forte - 1000002
	Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.) Assure® Slide Pill Swallowing Aid zero - 1000003
	Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.) AUTION Check Plus Controls - 102478
	Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.) Aution™ AU Control Solution - 73806
	Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. AUTION™ Diluent BAC - 73808
	Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. AUTION™ Diluent SED - 73807
	he AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathological Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. Aution™ Hybrid AU-4050 Chemical Analyzer - 14603
	Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. AUTION™ MAX AX-4022 Analyzer - 102974
	Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. AUTION™ MAX AX-4030 Analyzer - 14505
	Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. AUTION™ Sheath Solution - 73811
	Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. AUTION™ Staining Solution BAC - 73810
	Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. AUTION™ Staining Solution SED - 73809
	Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. AUTION™ Sticks 10EA Test Strips - 73526
	Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. AUTION™ Sticks 9EB Test Strips - 73627
	Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. AUTION™ Uriflet 9HA Test Strips - 73521
	The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used for the quantitative determination of Hemoglobin A1c (HbA1c) in human whole blood and hemolysate samples. Bi-level calibrators (low and high) lyophilized calibrator from human-sourced hemoglobin. Calibrator 80 - 103400
	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens. Concentrated Washing Solution 3 - 79053
	These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes commercially available freeze-dried controls and dilutes white blood samples. DILUENT 80 - 103399
	These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength. ELUENT 80A - 103395
	These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength. ELUENT 80B - 103396
	These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength. ELUENT 80CV - 103397
	Portable Blood Glucose Meter GLUCOCARD® 01 BLOOD GLUCOSE METER - 740001
	Portable Blood Glucose Meter GLUCOCARD® 01 BLOOD GLUCOSE METER - 740020
	Portable Blood Glucose Meter with Test Strips GLUCOCARD® 01 BLOOD GLUCOSE METER - 741100
	Blood Glucose Test Strips GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS - 720050
	Blood Glucose Test Strips GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS - 740050
	Portable Blood Glucose Meter GLUCOCARD® Vital™ BLOOD GLUCOSE METER - 760001
	Portable Blood Glucose Meter GLUCOCARD® Vital™ BLOOD GLUCOSE METER - 760020
	Portable Blood Glucose Meter with Test Strips GLUCOCARD® Vital™ BLOOD GLUCOSE METER - 761100
	Blood Glucose Test Strips GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS - 760010
	Blood Glucose Test Strips GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS - 760050
	Blood Glucose Test Strips GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS - 762050
	GLUCOCARD 01 Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482720056 is used as the assigned UDI for the Class I device.) GLUCOCARD® 01 Control - 720005
	GLUCOCARD 01 Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482740061 is used as the assigned UDI for the Class I device.) GLUCOCARD® 01 Control - 740006
	Portable Blood Glucose Meter GLUCOCARD® EXPRESSION Blood Glucose Monitoring System - 570001
	Portable Blood Glucose Meter GLUCOCARD® EXPRESSION Blood Glucose Monitoring System - 571100
	Blood Glucose Test Strips GLUCOCARD® EXPRESSION Blood Glucose Test Strips - 570010
	Blood Glucose Test Strips GLUCOCARD® EXPRESSION Blood Glucose Test Strips - 570050
	Blood Glucose Test Strips GLUCOCARD® EXPRESSION Blood Glucose Test Strips - 572050
	DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU GLUCOCARD® Expression™ Blood Glucose Monitoring System - 571188
	Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU GLUCOCARD® Expression™ Blood Glucose Monitoring System - 571199
	GLUCOCARD Expression Level 1 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570002 is used as the assigned UDI for the Class I device.) GLUCOCARD® Expression™ Level 1 Control Solution - 570005
	GLUCOCARD Expression Level 2 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570071 is used as the assigned UDI for the Class I device.) GLUCOCARD® Expression™ Level 2 Control Solution - 570007
	Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU GLUCOCARD® Shine Blood Glucose Monitoring System - 541199
	The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. GLUCOCARD® Shine Blood Glucose Monitoring System - 540001
	The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. GLUCOCARD® Shine Blood Glucose Monitoring System - 541100
	The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS - 540010
	The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS - 542050
	The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. GLUCOCARD® Shine Connex Blood Glucose Monitoring System - 543110
	The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. GLUCOCARD® Shine Express Blood Glucose Monitoring System - 544110
	GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the assigned UDI for the Class I device.) GLUCOCARD® Shine Level 1 Control Solution - 540005
	GLUCOCARD Shine Level 2 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540074 is used as the assigned UDI for the Class I device.) GLUCOCARD® Shine Level 2 Control Solution - 540007
	Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, IFU GLUCOCARD® Shine XL Blood Glucose Monitoring System - 542199
	The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. GLUCOCARD® Shine XL Blood Glucose Monitoring System - 542110
	GLUCOCARD Vital Meter Institutional multi-pack (4 GLUCOCARD Vital meter kits PN 760020) GLUCOCARD® Vital™ Blood Glucose Meter - 761177
	DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU GLUCOCARD® Vital™ Blood Glucose Monitoring System - 761188
	Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU GLUCOCARD® Vital™ Blood Glucose Monitoring System - 761199
	The GLUCOCARD W Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. For single-patient use only. GLUCOCARD® W Blood Glucose Monitoring System - 511100
	GLUCOCARD W Blood Glucose Test Strips are for use with the GLUCOCARD W blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. Alternative site testing (AST) should only be used during steady-state blood glucose conditions. The GLUCOCARD W blood glucose monitoring system is intended for self-testing outside the body (in vitro) by people with diabetes as an aid to monitor the effectiveness of diabetes control. This system is not intended for use on neonates, and it is not for the diagnosis or screening of diabetes. GLUCOCARD® W Blood Glucose Test Strips - 512050
	These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes whole blood samples and is used to wash the sample tubes. HEMOLYSIS WASHING SOLUTION 80H - 103398
	A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device. LANZO Lancing Device - 570015
	The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, AUTION MAX AX-4030 and AUTION MAX AX-4280 Urine Analyzers. The calibration is scheduled to occur monthly or as needed. S.G. Calibrator H - 100672
	Dry Chemistry Analyzer IVD, semi-automated SPOTCHEM™ EZ Analyzer - 18310
	Strip Description: For the in vitro quantitative determination of albumin concentration in human plasma from whole blood samples. SPOTCHEM™ II Albumin - 77109
	Strip Description: For the in vitro quantitative determination of ALP (alkaline phosphatase) activity in human plasma from whole blood samples. SPOTCHEM™ II ALP - 77115
	Strip Description: For the in vitro quantitative determination of ALT (alanine aminotransferease or glutamic pyruvic transaminase) activity in human plasma from whole blood samples. SPOTCHEM™ II ALT / GPT - 77111
	Strip Description: For the in vitro quantitative determination of amylase concentration in human plasma from whole blood samples. SPOTCHEM™ II Amylase - 77113
	Strip Description: For the in vitro quantitative determination of AST (aspartate aminotransferase or glutamic oxaloacetic transaminase, GOT) activity in human plasma from whole blood samples. SPOTCHEM™ II AST / GOT - 77110
	Strip Description: For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine concentration in human plasma from whole blood samples. SPOTCHEM™ II Basic Panel 1 - 77126
	Strip Description: For the in vitro quantitative determination of ALP, AST, and ALT activity, and total bilirubin and total protein concentration in human plasma from whole blood samples. SPOTCHEM™ II Basic Panel 2 - 77127
	Strip Description: For the in vitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples. SPOTCHEM™ II BUN - 77105
	Strip Description: For the in vitro quantitative determination of calcium concentration in human plasma from whole blood samples. SPOTCHEM™ II Calcium - 77107
	Strip Description: For the in vitro quantitative determination of creatine kinase (creatine phosphokinase or CPK) activity in human plasma from whole blood samples. SPOTCHEM™ II CPK - 77112
	Strip Description: For the in vitro quantitative determination of creatinine concentration in human plasma from whole blood samples. SPOTCHEM™ II Creatinine - 77116
	Strip Description: For the in vitro quantitative determination of fructosamine in human plasma from whole blood samples. SPOTCHEM™ II Fructosamine - 77117
	Strip Description: For the in vitro quantitative determination of GGT (y-glutamyltransferase or y-glutamyl tanspeptidase, Y-GPT) activity in human plasma from whole blood samples. SPOTCHEM™ II GGT - 77114
	Strip Description: For the in vitro quantitative determination of glucose in human plasma from whole blood samples. SPOTCHEM™ II Glucose - 77101
	Strip Description: For the in vitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples. SPOTCHEM™ II HDL-Cholesterol - 77122
	Strip Description: For the in vitro quantitative determination of inorganic phosphorus concentration in human plasma from whole blood samples. SPOTCHEM™ II Inorganic Phosphorous - 77118
	Strip Description: For the in vitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples. SPOTCHEM™ II LDH - 77120
	Strip Description: For the in vitro quantitative determination of HDL-cholesterol, total cholesterol, and triglyceride in human plasma from whole blood samples. SPOTCHEM™ II Lipid Panel - 77123
	Strip Description: For the in vitro quantitative determination of magnesium concentration in human plasma from whole blood samples. SPOTCHEM™ II Magnesium - 77119
	Strip Description: For the in vitro quantitative determination of total bilirubin concentration in human plasma from whole blood samples. SPOTCHEM™ II Total Bilirubin - 77106
	Strip Description: For the in vitro quantitative determination of total cholesterol in human plasma from whole blood samples. SPOTCHEM™ II Total Cholesterol - 77103
	Strip Description: For the in vitro quantitative determination of total protein in human plasma from whole blood samples. SPOTCHEM™ II Total Protein - 77108
	Strip Description: For the in vitro quantitative determination of triglycerides in human plasma from whole blood samples. SPOTCHEM™ II Triglycerides - 77104
	Strip Description: For the in vitro quantitative determination of uric acid concentration in human plasma from whole blood samples. SPOTCHEM™ II Uric Acid - 77102
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.3mL 31G x 15/64" (6mm) - 260314
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 1mL 31G x 15/64" (6mm) - 260316
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.3mL 29G x 1/2" (12mm) - 260291
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.3mL 30G x 1/2" (12mm) - 260301
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.3mL 30G x 5/16" (8mm) - 260302
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.3mL 31G x 5/16" (8mm) - 260311
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm) - 260312
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.5mL 29G x 1/2" (12mm) - 260292
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.5mL 30G x 1/2" (12mm) - 260303
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.5mL 30G x 5/16" (8mm) - 260304
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 0.5mL 31G x 15/64" (6mm) - 260315
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 1mL 29G x 1/2" (12mm) - 260293
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 1mL 30G x 1/2" (12mm) - 260305
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 1mL 30G x 5/16" (8mm) - 260306
	TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. TechLITE Insulin Syringes 1mL 31G x 5/16" (8mm) - 260313
	Sterile Single-Use Pen Needle samples. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE Pen Needle 4mm x 32g Sample 10's - 234032
	Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 234132
	Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 235131
	Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 236132
	Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 238131
	Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 230129
	Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 230929
	Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 232929
	Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 234932
	Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 235931
	Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 236131
	Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 238132
	Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. TechLITE PEN NEEDLES - 238931
	Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. TechLITE PEN NEEDLES - 232129
	Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. TechLITE PLUS PEN NEEDLES - 234232
	TechLITE Lancets 25g 100's. Load lancet into lancing device and twist off protective cap. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. (Primary UPC# 015482880125; Shipper UPC# 015482882549 are used as the assigned UDI for the Class I device.) TechLITE® Lancets - 880125
	TechLITE Lancets 26g 100's. The lancet is intended for capillary blood sampling. TechLITE® Lancets, 26g - 880126
	TechLITE Lancets 28g 100's. The lancet is intended for capillary blood sampling. TechLITE® Lancets, 28g - 880128

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