- Physicians Office Resource

VITROS Chemistry Products HbA1c Reagent
VITROS - 6842905

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen using a chemiluminescent immunoassay method.

Environmental Conditions

Special Storage Condition, Specify

Do not freeze

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PDJ

Device Name: Hemoglobin A1c Test System

Device Class: 2

Physical State: In-Vitro Diagnostic Reagent Kit

Definition: Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Assay detecting glycated hemoglobin

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Whole blood

Regulation Number: 862.1373

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 10758750030729

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

Device Id: 20758750030726

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10758750030729

Package Quantity: 18

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

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