Identity
- Trade Name
- IH-Card Group A,B FDA UDI
- Generic Name
- Anti-AB red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent; Gel card for use with IH-system; Optional add on to standard ABO typing cards; 48 cards of 6 microtubes FDA UDI
- Model / Reference
- 813141100 FDA UDI
- Description
- Blood Grouping Reagent; Gel card for use with IH-system; Optional add on to standard ABO typing cards; 48 cards of 6 microtubes FDA UDI
Identifiers
- Catalog Number
- 813141100 FDA UDI
- Primary DI / UDI-DI
- 07611969952113 FDA UDI
- GMDN Term
- Anti-AB 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-AB red blood cell grouping IVD, antibody
IH-Card Group A, B by Bio-Rad Medical Diagnostics GmbH — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI bf0c7eac-85b1-4ece-8e0c-44f27926bf4f 35 fields · synced Jun 8, 2026