The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC).

The ADAMS A1c HA
ADAMS™ A1c HA-8180V (UL) Analyzer - 100675

A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay).

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: 04987486001973

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