Syphilis Ab Rapid Test Strip (Serum/Plasma)

Primary DI

D-GCSYP-301aG5

Basic UDI-DI Code

B-GCSYP-301aG5

Reference

GCSYP-301a

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

Syphilis Ab Rapid Test Strip (Serum/Plasma) is a rapid, serological, immunochromatographic assay for the qualitative detection of antibodies (IgG, IgM and IgA) to Treponema Pallidum (TP) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with TP . Any reactive specimen with the Syphilis Ab Rapid Test Strip must be confirmed with alternative testing method(s) and clinical findings

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