Fluorion

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

Manufacturer

IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.

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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).