MAGICL Syphilis (CLIA)

Primary DI

06954414799040

Basic UDI-DI Code

B-06954414799040

Reference

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Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Getein Biotech, Inc.

MAGICL Syphilis (CLIA) is intended for the in vitro quantitative determination of total antibodies (IgG and IgM) to Treponema pallidum (Syphilis) in human serum or plasma. Clinically, it is mainly used to detect individuals may be infected with Syphilis, carry infectious Syphilis, and/or spread Syphilis. For professional and laboratory use only.

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