Identity
- Trade Name
- ALBAclone Anti-s (Monoclonal IgG) FDA UDI
- Generic Name
- Anti-S [MNS004] red blood cell grouping IVD, antibody FDA UDI
- Device Name
- The Anti-s reagent is for the in vitro detection and identification of the human s blood group antigen by Indirect Antiglobulin Test. FDA UDI
- Model / Reference
- Z187U FDA UDI
- Description
- The Anti-s reagent is for the in vitro detection and identification of the human s blood group antigen by Indirect Antiglobulin Test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471759 FDA UDI
- GMDN Term
- Anti-S [MNS004] 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
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-S [MNS004] red blood cell grouping IVD, antibody
ALBAclone Anti-s (Monoclonal IgG) by Alba Bioscience Limited — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anti-S [MNS004] red blood cell grouping IVD, antibody.
- Anti-s (MNS4) — DIAGAST
- Seraclone® Anti-s (MNS4) — Bio-Rad Medical Diagnostics GmbH
- ORTHO — Ortho-Clinical Diagnostics
- Anti-s — IMMUCOR, INC.
- Anti-s (Monoclonal) Gamma-clone — IMMUCOR, INC.
- Anti-s — AMERICAN NATIONAL RED CROSS
- Anti-s (Monoclonal) Gamma-clone — IMMUCOR, INC.
- ORTHOTM Sera Anti-s — ALBA BIOSCIENCE LIMITED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Alba Bioscience Limited
Sources (2)
- FDA UDI f2a96243-96c3-46c6-91aa-864e3d8b0cc1 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026