Identity
- Trade Name
- Wellcolex E.coli O157 FDA UDI
- Generic Name
- Escherichia coli antigen IVD, kit, agglutination FDA UDI
- Model / Reference
- R30959501 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501888 FDA UDI
- 510(k) Number
- K962028 FDA UDI
- FDA Product Code
- GNA FDA UDI
- GMDN Term
- Escherichia coli antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3255 FDA UDI
- 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
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: Escherichia coli antigen IVD, kit, agglutination
Wellcolex E.coli O157 by Remel Europe Limited — Class I — 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Remel Europe Limited
Sources (1)
- FDA UDI f28b3c13-f4cc-47c1-9c51-e605cdda3ee4 34 fields · synced Jun 8, 2026