Treponema pallidum (TP) Antibody Detection Kit (Magnetic particle CLIA)
by Tianjin Bioscience Diagnostic Technology Co., Ltd. 2 variants
Ref H201.02.089C6.020Model 500 TEST/KIT
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06973914380947 06973914380947 | Date3 Aug 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Treponema pallidum (TP) Antibody Detection Kit (Magnetic particle CLIA)
- Model / Reference
- 500 TEST/KIT, H201.02.089C6.020
- Primary DI / UDI-DI
- 06973914380947
- Basic UDI-DI
- B-06973914380947
- EMDN Code
- W0105010302 Syphilis antibody assays total
- Device Class
- Class IVD General
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000023301
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No