SYPHILIS DETECTION BY NA REAGENTS

Primary DI

D-400-038-C-MAXQ3

Basic UDI-DI Code

B-400-038-C-MAXQ3

Reference

400-038-C-MAX

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

BioGX B.V.

The BioGX Syphilis – OSR for BD MAXTM is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Treponema pallidum, and a DNA sample processing control (abbreviated as SPC). The assay is run on an automated DNA extraction and real-time PCR instrument with skin or genital lesions collections using Copan ESwabTM or Copan Universal Transport Media (UTMTM) from individuals at risk for presence of syphilis. Automated extraction of the sample DNA is done using the BD MAXTM ExKTM DNA-3 series extraction kits. The extraction kits contain the SPC DNA so no external addition of SPC is required. The SPC serves as both an extraction control and an internal amplification control (IAC). Each tube of multiplex PCR mix is provided in BioGX proprietary Sample-ReadyTM lyophilized format and contains all PCR primers, probes, enzyme, dNTPs, MgCl 2 , buffers, and other components required for real-time PCR-based analysis of one sample.

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