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Basic Information
- Primary DI
- 05060515140139
- Basic UDI-DI Code
- 506051514RPREF
- Reference
- NB013
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Newmarket Biomedical Ltd
Additional Description
Intended for the qualitative detection of reagin antibodies in human serum and EDTA plasma as an aid in the diagnosis of syphilis. The intended use population is patients with a suspected syphilis infection or at elevated risk of syphilis infection who attend STI clinics or other healthcare settings. This assay is not intended for automated use. This assay is not intended for blood screening or as a confirmatory assay on donor samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010399 | SYPHILIS REAGENTS OTHER |
Available In Countries
Related Devices
The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).