Fluorion

Primary DI

08698898740539

Basic UDI-DI Code

B-08698898740539

Reference

M0630102

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 VRE QLP 1.0 is a qualitative in vitro test that detects and differentiates vancomycine resistance genes (vanA and vanB). The analytic sensitivity is 1.0x102 copy/ml for VanA and 1.0 x102 copy/ml for VanB. A 66-146 bp region of the gene is amplified using sequence-specific primers. VanA sequence is detected with the FAM fluorophore, VanB sequence is detected with the Cy5 fluorophore and the internal control is detected with HEX fluorophore.

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