Identity
- Trade Name
- ALBA Elution Kit FDA UDI
- Generic Name
- Red cell antibody eluting IVD, kit FDA UDI
- Device Name
- The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. It is intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population. This pre-analytical procedure is performed manually. The ALBA Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte FDA UDI
- Model / Reference
- Z313U FDA UDI
- Description
- The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. It is intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population. This pre-analytical procedure is performed manually. The ALBA Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242477959 FDA UDI
- FDA Product Code
- KSG FDA UDI
- GMDN Term
- Red cell antibody eluting IVD, kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9600 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Red cell antibody eluting IVD, kit
ALBA Elution 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 e3c17f01-0ffe-421f-b5d0-f5a6ad08e388 35 fields · synced Jun 1, 2026