RapidFor™
by Vitrosens Biotechnology Inc. 36 variants
Ref VMD39STS01, VMD39
Active
CE IVDR CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number868499827VMD39STSW9 08684998273749 | Date25 Aug 2026 | StatusActive |
| European Union | CE/IVDR | Number868499827VMD39STSW9 08684998273749 | Date25 Aug 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Device Name
- Neisseria gonorrhoeae Test Kit
- Model / Reference
- VMD39STS01, VMD39
- Primary DI / UDI-DI
- 08684998273749
- Basic UDI-DI
- 868499827VMD39STSW9, B-08684998273749
- EMDN Code
- W0105010201 Gonococcal antigen detection
- Device Class
- Class CClass IVD General
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000026452
Other devices from Vitrosens Biotechnology Inc.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No