Identity
- Trade Name
- HbA1C CONTROL FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- This product is intended for in vitro diagnostic use in the quality control of HbA1c on clinical chemistry systems. FDA UDI
- Model / Reference
- HA5072 FDA UDI
- Description
- This product is intended for in vitro diagnostic use in the quality control of HbA1c on clinical chemistry systems. FDA UDI
Identifiers
- Catalog Number
- HA5072 FDA UDI
- Primary DI / UDI-DI
- 05055273208818 FDA UDI
- 510(k) Number
- K131999 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
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
No
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, control
HbA1C CONTROL by Randox Laboratories, Ltd. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI b1fa3ad9-0b15-4dce-8fa2-04c391c6605d 37 fields · synced May 30, 2026