Identity
- Trade Name
- IH-Panel 11 Papain FDA UDI
- Generic Name
- Antibody identification panel reagent red blood cell IVD, kit, agglutination FDA UDI
- Device Name
- Reagent Red Blood Cells; 0.6 ± 0.1 %; For Use in identification of unexpected antibodies with IH-Cards; 11 x 4 mL FDA UDI
- Model / Reference
- 814080100 FDA UDI
- Description
- Reagent Red Blood Cells; 0.6 ± 0.1 %; For Use in identification of unexpected antibodies with IH-Cards; 11 x 4 mL FDA UDI
Identifiers
- Catalog Number
- 814080100 FDA UDI
- Primary DI / UDI-DI
- 07611969952304 FDA UDI
- GMDN Term
- Antibody identification panel reagent red blood cell IVD, kit, agglutination 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Antibody identification panel reagent red blood cell IVD, kit, agglutination
IH-Panel 11 Papain 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 d5e16b28-2ab4-420b-a5e4-aa0ac805b26d 35 fields · synced May 30, 2026