Identity
- Trade Name
- Phadebact GC Positive Controls FDA UDI
- Generic Name
- Neisseria gonorrhoeae antigen IVD, control FDA UDI
- Model / Reference
- 10-5594-12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350049850245 FDA UDI
- FDA Product Code
- LSC FDA UDI
- GMDN Term
- Neisseria gonorrhoeae antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neisseria gonorrhoeae antigen IVD, control
Phadebact GC Positive Controls by Mkl Diagnostics AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Mkl Diagnostics AB
Sources (1)
- FDA UDI b056e86a-33af-4b5d-a6fc-e28148b90854 33 fields · synced May 30, 2026