HbA1c (Hemoglobin A1c Direct) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 - BL300
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free plasma haemoglobin in a clinical specimen, using an enzyme immunohistochemistry method. Free haemoglobin in plasma is indicative of red blood cell damage, and its detection is used as an aid in the diagnosis of haemolytic conditions (e.g., intravascular haemolysis, sickle cell anaemia, malaria) or to identify incompatible blood transfusions.
Environmental Conditions
- Reagent is stable on board a clinical analyzer for 30 days
- Reagent is stable when stored at 2-8° C until expiration date
- 8.00
- 2.00
Device Sizes
- Total Volume: 10 Milliliter
- Kit contains 2 R1, 2 R2 and 1 package insert
- Total Volume: 25 Milliliter
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: 00817302022155
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