Identity
- Trade Name
- Wellcogen Strep B FDA UDI
- Generic Name
- Multiple meningitis-associated bacteria antigen IVD, kit, agglutination FDA UDI
- Model / Reference
- R30858701 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501574 FDA UDI
- 510(k) Number
- K820069 FDA UDI
- FDA Product Code
- GTZ FDA UDI
- GMDN Term
- Multiple meningitis-associated bacteria antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 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: Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
Wellcogen Strep B by Remel Europe Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple meningitis-associated bacteria antigen IVD, kit, agglutination.
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- Wellcogen S pneumoniae — REMEL EUROPE LIMITED · Class I
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 0a84c7e5-089c-4431-a932-b45241372250 34 fields · synced May 30, 2026