- Physicians Office Resource

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

Special Storage Condition, Specify

Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C

Special Storage Condition, Specify

Unopened reagents are stable to expiration date with stored at 2 to 8°C

Storage Environment Temperature - Degrees Celsius

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

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 Identifiers

Device 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

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