Identity
- Trade Name
- Biotestcell® A2 FDA UDI
- Generic Name
- Group A2 Rh (D) negative reagent red blood cell IVD, antigen FDA UDI
- Device Name
- Reagent Red Blood Cells; Biotestcell® A2; 3.0 - 3.4%; pooled cells for reverse grouping by the tube test; 10ml FDA UDI
- Model / Reference
- 816047100 FDA UDI
- Description
- Reagent Red Blood Cells; Biotestcell® A2; 3.0 - 3.4%; pooled cells for reverse grouping by the tube test; 10ml FDA UDI
Identifiers
- Catalog Number
- 816047100 FDA UDI
- Primary DI / UDI-DI
- 07611969952625 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
Biotestcell® 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 eac618da-e39d-4ada-a3d5-d9d7601bbd89 35 fields · synced Jun 8, 2026