Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
ONE STEP Anti-TP Rapid Test (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974521001843
- Basic UDI-DI Code
- B-06974521001843
- Reference
- SUPG007025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shenzhen Superbio Technology Co.,Ltd.
Additional Description
The test is assay for the qualitative detection of the treponema pallidum antibody in human serum, plasma, or whole blood samples. The test is a screening test and all positives must be confirmed using an alternate test such as western blot. The test is intended for healthcare professional use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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