Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04260658551538
- Basic UDI-DI Code
- B-04260658551538
- Reference
- 8.04.41.0.0020
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Atlas Medical GmbH
Additional Description
Syphilis Antibody Rapid Tests are manual rapid chromatographic immunoassay for the qualitative detection of early treponemal IgM/IgG antibodies against Syphilis in human whole blood, serum and plasma to provide serological evidence of past/current Syphilis infections when followed by a non-treponemal test.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010302 | SYPHILIS ANTIBODY ASSAYS TOTAL |
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