Identity
- Trade Name
- Coombs Control Cells FDA UDI
- Generic Name
- Multiple immunohaematology test IVD, control FDA UDI
- Device Name
- For use in quality control of anti-human globulin procedures. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 1 x 10 ml FDA UDI
- Description
- For use in quality control of anti-human globulin procedures. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 213630 FDA UDI
- Primary DI / UDI-DI
- 07640137340599 FDA UDI
- GMDN Term
- Multiple immunohaematology test IVD, control FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Multiple immunohaematology test IVD, control
Coombs Control Cells by Medion Grifols Diagnostics AG — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medion Grifols Diagnostics AG
Sources (1)
- FDA UDI cd7c112d-ed3c-4d72-b2da-682bc16a5a30 34 fields · synced Jun 8, 2026