HCY (Homocysteine) w/ cal 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 - CC202
Device Description
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of homocysteine in a clinical specimen.
Environmental Conditions
- Unopened reagents are stable to expiration date when stored at 2 to 8°C
- Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
- 8.00
- 2.00
Device Sizes
- Total Volume: 5 Milliliter
- Total Volume: 2.5 Milliliter
- Total Volume: 20 Milliliter
- Kit contains 2 HCY Reagent cartridges, 1 C1 Calibrator, 1 C2 Calibrator,1 Reagent Kit Package insert and 2 User Defined Parameters
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LPS
Device Name: Urinary Homocystine (Nonquantitative) Test System
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1377
Third Party Flag: Y
Medical Specialty: CH
Code: JJX
Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1660
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00817302020120
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A