HbA1c (Hemoglobin A1c) w/ lysis buffer 2 x 90 tests
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c REAGENT CC300 - CC300
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.
Environmental Conditions
- Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
- Unopened reagents are stable to expiration date with stored at 2 to 8°C
- 8.00
- 2.00
Device Sizes
- Total Volume: 5.5 Milliliter
- Total Volume: 25 Milliliter
- Total Volume: 7 Milliliter
- Total Volume: 22 Milliliter
- Kit contains 2 cartridges which contain R1, R2 & R1B, 2 Lysis buffer bottles 1 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: LCP
Device Name: Assay, Glycosylated Hemoglobin
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
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: 864.7470
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 00817302020083
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