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Clia Waived Diagnostic Devices

PRODUCT DIRECTORY

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CLIA-Waived Diagnostic Devices

Analyzers - CLIA-Waived Cholesterol - CLIA-Waived Hemoglobin A1c - CLIA-Waived Lipid Panel and Triglyceride Analyzers - CLIA-Waived Urine Analyzers - Crosslinked N-telopeptide (NTx) of Collagen Type 1 - Glucose Analyzers - Hemoglobin Analyzers - Ketone Analyzers - Microhematocrit Centrifuges - Point of Care (POC) Data Management Systems -

Diagnostics

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		Afinion Analyzer System The Afinion point-of-care system is a simple, fast and reliable way to perform testing in the physicians’ office, clinic or hospital point-of-care setting. The system and the first test for HbA1c are FDA 510(k) cleared and National Glycohemoglobin Standardization Program (NGSP) Certified, as well as CLIA waived. The HbA1c test is performed using simple pin-prick blood sampling and provides results in only three minutes....

		in2itª A1C This A1c Point of Care analyzer is a fully automated system designed for simplicity, convenience and speed in near patient testing, providing results while the patient waits. The in2it™ assay requires only 10µL of capillary or venous blood and utilizes boronate affinity chromatography for results traceable to the worldwide DCCT reference. The in2it™ is FDA cleared for prescription home use, CLIA waived, and NGSP certified....

		Cholestech GDX System The Cholestech GDX System delivers an unmatched combination of speed, accuracy and affordability making it the ideal solution for assessing and monitoring a patient's A1C levels. The CLIA-waived* Cholestech GDX requires only a simple fingerstick and delivers A1C results in less than 5 minutes. The system is a proven and time-tested having received full NGSP† certification every year since its introduction in 2001....

		iSTAT® Weighing only 18 ounces, the i-STAT® System is an easy-to-use, hand-held analyzer capable of providing time-sensitive test results in just minutes. To perform a test, the user places two or three drops of whole blood on the test cartridge, which is then inserted into the analyzer. A new test cartridge is used for each patient. Utilizing test-specific cartridges that are fully self-contained, the i-STAT® System delivers lab-accurate testing for blood gases, electrolytes, chemistries, coagulation, hematology, glucose and cardiac markers....

		STAT-Site The STAT-Site® MHgb Test System is a portable hemoglobin analyzer that fits in the palm of your hand. It provides precise hemoglobin analysis in seconds. Self-prompting graphics guide you through the simple test procedure. Hemoglobin testing is quick and easy reducing personnel training and improving workflow efficiency. It also includes automatic calibration with each lot number of test cards and available multi-level Hemoglobin Controls. Point-of-care hemoglobin testing is routinely performed in OB/GYN, family and pediatric practices along with public health clinics....

		ICON® DS Strep A ICON® DS Strep A is a rapid immunochromatographic assay for the qualitative detection of Group A Strep antigen directly from a throat swab specimen. ICON® DS Strep A is a simple, easy-to-use CLIA-waived dipstick format test. With outstanding performance, even in low colony count samples, ICON® DS Strep A leaves little chance for misdiagnosis, minimizing the chance of rheumatic fever or over-prescription of antibiotics. In as little as five minutes, you will have accurate results so you can begin your patients treatment immediately and confidently. ...

		ToxCup 7 Panel Drug Cup (25 Cups) CLIAwaived ToxCup Drug Tests, FDA Cleared One Step drug screen cup for the rapid detection of seven drugs (THC,COC,OPI300,MET 500,BZO,BAR,OXY 100) of abuse. Simple design that integrates sample collection, drug testing and shipment for confirmation-clia waived instant drug testing screening kits....

		BinaxNow RSV Test Test Kit (10) Respiratory Syncytial Virus (RSV) Test Kits, the NOW RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) fusion protein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. FDA Cleared and CLIAwaived-BinaxNow RSV Test Test Kit....

		Hemoglbin A1c Test InView (20 Disposable Tests) Hemoglobin A1c Test, blood glucose A1c Now. InView test provides quantitative measurement of the percent of glycated hemoglobin (A1c) levels in capillary (fingerstick) or venous whole blood samples. The test is for prof. use to monitor glycemic control in people with diabetes-Hemoglobin A1c Test InView....

		Quidel QuickVue Influenza A/B Tests (25) QuickVue Influenza (FLU) A+B Test Kits (dipstick format), allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab,nasal wash and or nasal aspirate specimens. FDA Cleared and CLIAwaived-Quidel QuickVue Influenza A/B. EXP:11/2009...

		iScreen CLIAwaived Mono Test Kit (20) Mononucleosis (Mono) Rapid Test Kits, FDA Cleared, CLIAwaived rapid mono test for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood, serum and plasma. Not approved for use in pediactric patients-iScreen CLIAwaived Mono Test Kit....

		HemoSure Fecal Occult Blood Test (30 Pack) Fecal Occult Blood Test (FOBT), Hemosure is a sandwich dye conjugate immunoassay to selectively identify human hemoglobin in test samples with a high degree of sensitivity and specificity. This test is CLIA waived and FDA approved-HemoSure Fecal Occult Blood Test....

		CLIAwaived 11 Panel Drug Test Card (25 Per Box) CLIAwaived 11 Panel Drug Test Cassette, FDA Cleared with integrated positive and negative controls. This card will detect COC, THC, OPI, AMP, PCP, BZO, BAR, MDMA, PPX, OXY, TCA. Results stable for 8 hours-clia waived drug testing-clia waived instant drug testing screening kits....

		HCG Pregnancy Urine Test Cassette (40 Per Box) HCG Pregnancy Urine Test Cassette, FDA Cleared and CLIAwaived HCG Pregnancy Test Device (Urine Only)-HCG Pregnancy Urine Test Cassette....

		Hgb Pro® Meter (1 meter + 100 strips) The Hgb Pro Professional Hemoglobin Testing System® is portable and easy to use. Simply insert a test strip into the meter, and place a small drop of blood onto the strip. Since the Hgb Pro is self-calibrating, no additional calibration is required. Includes 1 box of 100 testing strips. ...

		iScreen Strep A Test Kit (25) iScreen Strep A Rapid Test Strip, is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. FDA Cleared and CLIAWaived-Rapid Strep Test for Strep Throat....

		QuikTox 11 Panel Drug Test Card (25 Tests) QuickTox multiple drugs of abuse dip card, that allows for easy mix and match of tests. This test will detect the following 11 drugs: THC, COC, OPI, mAMP, AMP, PCP, BZO, BAR, MTD, OXY, and MDMA. FDA Cleared and CLIAwaived-QuikTox 11 Panel Drug Test Card....

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