Syphilis Ab Rapid Test Cassette (Serum/Plasma)

Primary DI

D-GCSYP-302aG8

Basic UDI-DI Code

B-GCSYP-302aG8

Reference

GCSYP-302a

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 Cassette (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 Cassette 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).