SYPHILIS ANTIBODY ASSAYS TOTAL

Primary DI

06936791010093

Basic UDI-DI Code

B-06936791010093

Reference

MD0101-96

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

This product is made of the microwell plate coated with treponema pallidum (TP) TP15, TP17 and TP47 antigen, horseradish peroxidase (HRP)-marked TP15, TP17 and TP47 antigen and other reagents. It is intended for use of qualitatively testing the treponema pallidum antibody in human serum or plasma. Syphilis is caused by treponema pallidum. It is a widely spread venereal disease. It has a long disease course, invades the genital and skin at an early stage and all organs in the whole body at a later stage and generates various symptoms and vital signs. Its lesion can affect almost each organ in the human body. Syphilis can be transmitted among the population through sexual behavior and from mother to the fetus, endangering the next generation. Testing of TP antibody has important significance for safety, prevention and treatment of syphilis.

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