Third Generation Double Antigen Sandwich Enzyme Linked Immunosorbent Assay for detection of antibodies to Treponema Pallidum in human serum or plasma - India CDSCO Medical Device Registration
Third Generation Double Antigen Sandwich Enzyme Linked Immunosorbent Assay for detection of antibodies to Treponema Pallidum in human serum or plasma is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000113_f4d863497d976e109a7b278f817d56d3_deaaeec67e4ff7d875b9e3544b8a87ba. This device is marketed under the brand name Device. The license holder is QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Goa.
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Brand Name
Device
Device Class
Approving Authority
Sub Zonal Goa
Product Information
Trepolisa 3.0 is intended to be used for the detection of total antibodies (Device) to Treponema pallidum in human serum or plasma
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