HbA1c Advanced
AU - B93009
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) in a clinical specimen, using a nephelometry/turbidimetry method.
Environmental Conditions
- Store at 2 to 8 degrees celcius
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
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 IdentifiersDevice Id: 15099590012120
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