Identity
- Trade Name
- Seraclone Control AB0+Rh FDA UDI
- Generic Name
- Antisera matrix (non-reactive) IVD, control FDA UDI
- Device Name
- Reagent for the negative control in ABO and RH typing with Seraclone ABO and Rh reagent for tube test; 10 ml FDA UDI
- Model / Reference
- 805171100 FDA UDI
- Description
- Reagent for the negative control in ABO and RH typing with Seraclone ABO and Rh reagent for tube test; 10 ml FDA UDI
Identifiers
- Catalog Number
- 805171100 FDA UDI
- Primary DI / UDI-DI
- 07611969950874 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- Antisera matrix (non-reactive) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9650 FDA UDI
- 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
HCT/P
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: Antisera matrix (non-reactive) IVD, control
Seraclone Control AB0+Rh by Bio-Rad Medical Diagnostics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK080012 also covers:
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI 14738ebf-7913-4ead-9c1a-bbd75c03dc84 37 fields · synced May 29, 2026