Rapid Syphilis Antibody Test-Device - India CDSCO Medical Device Registration
Rapid Syphilis Antibody Test-Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000068_25e1c834f2a39e36cbd8237e855fb20a_d11a2ffb70a990504034fe99bb259b10. This device is marketed under the brand name Rapichek Syphilis. The license holder is Oxalis Diagnostics 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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Brand Name
Rapichek Syphilis
License Holder
Oxalis Diagnostics Pvt. LtdDevice Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
Rapid Syphilis Antibody Test device is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to Treponema pallidum in human blood/serum/plasma . It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with Treponema pallidum. Alternative test method(Rapichek Syphilis) should be considered to confirm the test result obtained by this device.
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