Identity
- Trade Name
- Biotestcell® Pool FDA UDI
- Generic Name
- Pooled antibody screening reagent red blood cell IVD, antigen FDA UDI
- Device Name
- Reagent Red Blood Cells; 3.0 - 3.4%; pooled cells for use in detection of unexpected antibodies with TANGO instruments; 10ml FDA UDI
- Model / Reference
- 816065100 FDA UDI
- Description
- Reagent Red Blood Cells; 3.0 - 3.4%; pooled cells for use in detection of unexpected antibodies with TANGO instruments; 10ml FDA UDI
Identifiers
- Catalog Number
- 816065100 FDA UDI
- Primary DI / UDI-DI
- 07611969952670 FDA UDI
- GMDN Term
- Pooled antibody screening 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: Pooled antibody screening reagent red blood cell IVD, antigen
Biotestcell® Pool by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pooled antibody screening 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI 61c82ff6-8b6d-4b40-815e-ef964a07f00d 35 fields · synced Jun 8, 2026