Identity
- Trade Name
- Afinion HbA1c Calibration Verification FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert. FDA UDI
- Model / Reference
- 1116792 FDA UDI
- Description
- HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert. FDA UDI
Identifiers
- Catalog Number
- 1116792 FDA UDI
- Primary DI / UDI-DI
- 07070060014722 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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, control
Afinion HbA1c Calibration Verification by Abbott Diagnostics Technologies AS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glycated haemoglobin (HbA1c) IVD, control.
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- Liquichek — Bio-Rad Laboratories · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Abbott Diagnostics Technologies AS
Sources (1)
- FDA UDI 6b8bc1e5-371a-432f-ba12-a2b0e1621001 35 fields · synced May 30, 2026