Identity
- Trade Name
- AlbaQ-Chek® FDA UDI
- Generic Name
- Red blood cell count IVD, control FDA UDI
- Device Name
- AlbaQ-Chek® is intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques. FDA UDI
- Model / Reference
- Z498 FDA UDI
- Description
- AlbaQ-Chek® is intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242470943 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- Red blood cell count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Red blood cell count IVD, control
AlbaQ-Chek® by Alba Bioscience Limited — 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
- Alba Bioscience Limited
Sources (1)
- FDA UDI 4f8caf8a-e49c-4a4f-bd20-d1808898425b 34 fields · synced May 30, 2026