Syphilis Rapid Test

Primary DI

06936983109604

Basic UDI-DI Code

6970277510000FXM

Reference

ISY-N402J-40

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Hangzhou Alltest Biotech.Co.,Ltd.

The Syphilis Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma as an aid in the diagnosis of Syphilis. The product is intended to be used by trained laboratory personnel. For laboratory use only. The test provides preliminary test results. Negative results will not preclude Treponema Pallidum infection and they can't be used as the sole basis for treatment or other management decision. Not for Self-testing use. Not for near-patient use. Not for blood donor screening.

The Basic UDI-DI associated with this device has 9 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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