These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength.

These products are used with the ADAMS A1c HA
ELUENT 80A - 103395

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 14987486015090

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987486015093

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 04987486015093

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