Identity
- Trade Name
- IH-Cell A2 FDA UDI
- Generic Name
- Group A2 Rh (D) negative reagent red blood cell IVD, antigen FDA UDI
- Device Name
- Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled cells for reverse grouping with IH-Cards; 1 x 10 mL FDA UDI
- Model / Reference
- 814020100 FDA UDI
- Description
- Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled cells for reverse grouping with IH-Cards; 1 x 10 mL FDA UDI
Identifiers
- Catalog Number
- 814020100 FDA UDI
- Primary DI / UDI-DI
- 07611969952250 FDA UDI
- GMDN Term
- Group A2 Rh (D) negative reagent red blood cell IVD, antigen 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
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: Group A2 Rh (D) negative reagent red blood cell IVD, antigen
IH-Cell A2 by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Group A2 Rh (D) negative reagent red blood cell IVD, antigen.
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 cea95f28-cc4f-4ee5-9b5e-7dee57107bf0 35 fields · synced May 30, 2026