D-100 Hemoglobin Testing System

D
D-100 - 12008984

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).

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LDM

Device Name: Instrumentation, High Pressure Liquid Chromatography

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: TX

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: 862.2260

Third Party Flag: N

Medical Specialty: CH

Device Id: 03610522060696

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