Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 06950996002363
- Basic UDI-DI Code
- B-06950996002363
- Reference
- GCSYP-402a
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
Additional Description
Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid, serological, immunochromatographic assay for the qualitative detection of antibodies (IgG, IgM and IgA) to Treponema Pallidum (TP) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with TP. Any reactive specimen with the Syphilis Ab Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090105 | SYPHILIS - RT & POC |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).