Fluorion
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
- 08698898740072
- Basic UDI-DI Code
- B-08698898740072
- Reference
- M0030102
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
Additional Description
Fluorion MTBC QLP 2.1 Real-Time PCR Kit detects M. tuberculosis DNA in human biological samples. The analytic sensitivity is 8.08x101 copies/ml. A 105 bp region within the insertion sequence (IS) is amplified using sequence-specific primers and the detection is accomplished using the FAM filter pair. To control PCR inhibition an internal control is incorporated into the system. The internal control is detected with the Cy5 during data collection. The internal control is added into the PCR reaction mix.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010703 | MYCOBACTERIAL DETECTION BY NA REAGENTS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).