Identity
- Trade Name
- ALBAclone Anti-A FDA UDI
- Generic Name
- Anti-A red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent, ALBAclone Anti-A, Murine Monoclonal IgM for slide and tube techniques. FDA UDI
- Model / Reference
- Z001U FDA UDI
- Description
- Blood Grouping Reagent, ALBAclone Anti-A, Murine Monoclonal IgM for slide and tube techniques. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471421 FDA UDI
- GMDN Term
- Anti-A red blood cell grouping IVD, antibody FDA UDI
Classification
- 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
No
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: Anti-A red blood cell grouping IVD, antibody
ALBAclone Anti-A by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Anti-A red blood cell grouping IVD, antibody.
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- BIOCLONE — Ortho-Clinical Diagnostics
- Anti-A (AB01) — DIAGAST
- Anti-A (Murine Monoclonal) Series 1 — IMMUCOR, INC.
- Seraclone® Anti-A (ABO1) — Bio-Rad Medical Diagnostics GmbH
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Alba Bioscience Limited
Sources (1)
- FDA UDI 03aded0a-4793-46e6-ac37-4e9a444882de 34 fields · synced May 30, 2026