MYCOBACTERIA REAGENTS - OTHER
Basic Information
- Primary DI
- 04049095200052
- Basic UDI-DI Code
- 4049095TC88060000MU
- Reference
- TC8806
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- R-Biopharm AG
Additional Description
For in-vitro diaqnostic use. The RIDASCREENยฎ TB is a manual enzyme immunoassay for the direct quantitative detection of interferon gamma-induced protein 10 (IP-10) from human plasma samples of individuals with suspected Mycobacterium tuberculosis infection (including disease). This IVD test is intended for use in conjunction with the RIDAยฎTB Tubes for in-vitro stimulation with specific M. tuberculosis antigens. The RIDASCREENยฎ TB is a diagnostic aid for indirect detection of M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessments, radiographic examinations, and other clinical and laboratory findings. Negative results do not rule out M. tuberculosis infection and should not be used as the sole basis for diagnosis. The product is intended for professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010799 | MYCOBACTERIA REAGENTS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).