Anatolia Geneworks

Primary DI

08684198020563

Basic UDI-DI Code

868001894PCRSTDCNMPN050EF

Reference

ABMNC2

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.

Bosphore CT/NG/MG Panel Kit v1 is an in vitro diagnostic Real Time- Polymerase Chain Reaction (RT-PCR) kit intended for qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium bacterial DNA extracted from vaginal swab, cervical swab, endocervical swab, urethral swab, urine, eye swab in individuals suspected of being infected with related bacteria by health authorities. The kit is in multiplex format and aims to diagnose the disease by detecting the presence of CT/NG/MG bacterial DNA qualitatively. Positive results indicate the presence of CT/NG/MG bacterial DNA. In case of a positive result, the risk of infection by other bacteria or viruses are not excluded. Negative results do not avert CT/NG/MG infection and should not be used as the final basis for patient management decisions. Positive and negative results must be combined with clinical observations, patient history, and epidemiological information. Bosphore CT/NG/MG Panel Kit v1 is intended for use by qualified and trained clinical laboratory personnel who have received the required training for analysing Real-Time PCR data and in vitro diagnostic procedures.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).