Device intended for measurement of HbA1c in whole blood using capillary electrophoresis
CAPI 3 Hb A1c - 2515
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 liquid chromatography method.
Environmental Conditions
- 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: JJX
Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
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: 862.1660
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
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 IdentifiersDevice Id: 03607360025154
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