Identity
- Trade Name
- ALBAsure QC Kit FDA UDI
- Generic Name
- Red blood cell count IVD, control FDA UDI
- Device Name
- Qualitative controls for the quality control of routine blood bank reagents. The ALBAsure® QC Kit is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods. FDA UDI
- Model / Reference
- Z481U FDA UDI
- Description
- Qualitative controls for the quality control of routine blood bank reagents. The ALBAsure® QC Kit is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471353 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
Yes
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: Red blood cell count IVD, control
ALBAsure QC Kit 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 b939f7d0-5c9c-40d5-a12b-661ace34d9c7 34 fields · synced Jun 6, 2026