Syphilis Antibody Test - India CDSCO Medical Device Registration

Syphilis Antibody Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000070_b06699a2c47d9765a702c206ca43b2f6_0db21a7eadb4c517100a3fa7fb56f76c. This device is marketed under the brand name PathoCatch. The license holder is M/s Mylab Discovery Solutions Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class D

Syphilis Antibody Test

UID: MFG/IVD/2021/000070_b06699a2c47d9765a702c206ca43b2f6_0db21a7eadb4c517100a3fa7fb56f76c

Brand Name

PathoCatch

License Holder

M/s Mylab Discovery Solutions Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Syphilis Antibody test (PathoCatch) is an immunoassay for the rapid and visual detection of antibodies to Treponema pallidum in human serum or plasma or whole blood to aid in the diagnosis and screening of Syphilis. This kit is intended for professional and self-testing