Identity
- Trade Name
- SELECTOGEN FDA UDI
- Generic Name
- Antibody screening reagent red blood cell IVD, kit, agglutination FDA UDI
- Device Name
- SELECTOGEN 2X10ML FDA UDI
- Model / Reference
- 719610 FDA UDI
- Description
- SELECTOGEN 2X10ML FDA UDI
Identifiers
- Catalog Number
- 719610 FDA UDI
- Primary DI / UDI-DI
- 10758750004041 FDA UDI
- GMDN Term
- Antibody screening reagent red blood cell IVD, kit, agglutination 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
Yes
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: Antibody screening reagent red blood cell IVD, kit, agglutination
Selectogen by Ortho-Clinical Diagnostics — 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
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI bdb5fb9d-c598-4459-a190-5ada3e2f0e3e 35 fields · synced May 30, 2026