Identity
- Trade Name
- Afinion HbA1c Dx FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
- Device Name
- Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole blood including diagnosis. COntetns: 15 test cartridges, 1 package insert. FDA UDI
- Model / Reference
- 1116794 FDA UDI
- Description
- Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole blood including diagnosis. COntetns: 15 test cartridges, 1 package insert. FDA UDI
Identifiers
- Catalog Number
- 1116794 FDA UDI
- Primary DI / UDI-DI
- 07070060014555 FDA UDI
- FDA Product Code
- PDJ FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1373 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, reagent
Afinion HbA1c Dx by Abbott Diagnostics Technologies AS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Abbott Diagnostics Technologies AS
Sources (1)
- FDA UDI 5e155060-a02f-46f0-a07a-8bc61a6f3cf7 35 fields · synced May 30, 2026