Identity
- Trade Name
- IH-Card Anti-K FDA UDI
- Generic Name
- Anti-K (KEL001) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent; Gel card for use with the IH-system; Card for single K (KEL1) antigen typing; 48 cards of 6 microtubes FDA UDI
- Model / Reference
- 813281100 FDA UDI
- Description
- Blood Grouping Reagent; Gel card for use with the IH-system; Card for single K (KEL1) antigen typing; 48 cards of 6 microtubes FDA UDI
Identifiers
- Catalog Number
- 813281100 FDA UDI
- Primary DI / UDI-DI
- 07611969962433 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
Yes
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
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
IH-Card Anti-K by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-K (KEL001) red blood cell grouping IVD, antibody.
- ALBAclone Anti-K (Monoclonal) — ALBA BIOSCIENCE LIMITED
- Anti-K (KEL1) — DIAGAST
- ORTHOTM Sera Anti-K — ALBA BIOSCIENCE LIMITED
- Beckman Coulter® PK® Systems Anti-K (MS56) — DIAGAST
- ORTHO — Ortho-Clinical Diagnostics
- Anti-K (Human Monoclonal) Series 2 — IMMUCOR, INC.
- DG Gel 8 Anti-K — DIAGNOSTIC GRIFOLS SA
- Anti-K — IMMUCOR, INC.
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
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI 44ff7841-a3d6-4575-a80e-d6e38fdc39a6 35 fields · synced May 30, 2026