ChainFor™
by Vitrosens Biotechnology Inc. 132 variants
Ref PCR81Model CFP81P100
Active
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 | NumberB-08684595034781 08684595034781 | Date27 Jul 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- Withdrawn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 Active
Specification
- Device Name
- Haemophilus ducreyi qPCR Kit
- Model / Reference
- CFP81P100, PCR81
- Primary DI / UDI-DI
- 08684595034781
- Basic UDI-DI
- B-08684595034781, 868511580PCR81JL
- EMDN Code
- W0105900102 Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus
- Device Class
- Class IVD GeneralClass C
- 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