MYCOBACTERIUM REALTIME PCR KIT
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Basic Information
- Primary DI
- 08436610290463
- Basic UDI-DI Code
- 843604032RTPCR01601W4
- Reference
- RTPCR016-LP
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Vircell, S.L
Additional Description
Real Time RT-PCR kit to detect nucleic acid from Mycobacterium tuberculosis complex (MTBC), Mycobacterium avium complex (MAC) and Mycobacterium abscessus complex (MABSC) species and other non-tuberculous mycobacteria (NTM) in human sputum samples. The device is intended to be used with general population with suspected infection by the microorganism. The test is a qualitative and automated assay, intended to be used as an aid to diagnosis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010703 | MYCOBACTERIAL DETECTION BY NA REAGENTS |
Available In Countries
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Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).