Identity
- Trade Name
- Solidscreen II Anti-D (RH1) Blend FDA UDI
- Generic Name
- Partial (variant) Rh(D) category VI/weak Rh(D) red cell grouping IVD, antibody FDA UDI
- Device Name
- Solidscreen II Human Monoclonal Blend (BS221/H41 11B7); for Solidscreen II with TANGO instruments; 5ml FDA UDI
- Model / Reference
- 806530100 FDA UDI
- Description
- Solidscreen II Human Monoclonal Blend (BS221/H41 11B7); for Solidscreen II with TANGO instruments; 5ml FDA UDI
Identifiers
- Catalog Number
- 806530100 FDA UDI
- Primary DI / UDI-DI
- 07611969951512 FDA UDI
- GMDN Term
- Partial (variant) Rh(D) category VI/weak Rh(D) red 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
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: Partial (variant) Rh(D) category VI/weak Rh(D) red cell grouping IVD, antibody
Solidscreen II Anti-D (RH1) Blend by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 19854336-11ce-4051-9f8c-b52f05ed7efd 35 fields · synced Jun 1, 2026