Identity
- Trade Name
- ORTHOTM Sera Anti-K FDA UDI
- Generic Name
- Anti-K (KEL001) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- The Anti-K reagent (KEL1) is for the qualitative in vitro detection of human K positive red blood cells by the direct agglutination test. FDA UDI
- Model / Reference
- 6904552 FDA UDI
- Description
- The Anti-K reagent (KEL1) is for the qualitative in vitro detection of human K positive red blood cells by the direct agglutination test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10758750013074 FDA UDI
- GMDN Term
- Anti-K (KEL001) 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
No
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-K (KEL001) red blood cell grouping IVD, antibody
ORTHOTM Sera Anti-K by Alba Bioscience Limited — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anti-K (KEL001) red blood cell grouping IVD, antibody.
- Anti-K (KEL1) — DIAGAST
- IH-Card Anti-K — Bio-Rad Medical Diagnostics GmbH
- Beckman Coulter® PK® Systems Anti-K (MS56) — DIAGAST
- ORTHO — Ortho-Clinical Diagnostics
- Anti-K (Human Monoclonal) Series 2 — IMMUCOR, INC.
- IH-Card Anti-K — Bio-Rad Medical Diagnostics GmbH
- DG Gel 8 Anti-K — DIAGNOSTIC GRIFOLS SA
- IH-Card Anti-K — Bio-Rad Medical Diagnostics GmbH
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 de7857c6-cbef-45e8-9d06-5634521c8a0a 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026