STD-Finder® 2SMART

Primary DI

08719327116128

Basic UDI-DI Code

B-08719327116128

Reference

PF3200-2S

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

PathoFinder B.V.

The STD-Finder 2SMART (Single tube Multiplex Amplification in RealTime) Kit is a non-automated qualitative multiplex PCR-based test to aid the diagnosis of sexually transmitted infections (STI) in humans suspected of having an STI by detecting and differentiating 5 species of bacteria, 2 DNA viruses and 1 parasite: Chlamydia trachomatis (detecting genital chlamydia serovars D-K as a group and distinguishing L serovars causing Lymphogranuloma Venereum (LGV) as a separate group), Mycoplasma genitalium, Neisseria gonorrhoeae (distinguishing N. gonorrhoeae strains with a mosaic penA gene conferring cephalosporin resistance), Treponema pallidum, Ureaplasma urealyticum, herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and Trichomonas vaginalis. This test is intended for use on nucleic acids extracted from urine or from genital, oropharyngeal or anal swabs. The STD-Finder 2SMART is for use with LightCycler® 480 / cobas® z480 (Roche), Rotor-Gene® Q / Rotor-Gene® Q MDx (QIAGEN) and QuantStudio™ 5 (Thermo Fisher Scientific). This test device is not intended to be used to detect the presence of or exposure to or for screening for transmissible agents in blood, blood components, cells, tissues, organs or any of their derivatives in order to assess their suitability for transfusion, transplantation or cell administration.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).