HCV Ab Test - India CDSCO Medical Device Registration

HCV Ab Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_bb35c69b8f76fa5749c56131e53bd4f6_136448321c863e937ddd205719ce6afd. This device is marketed under the brand name PathoCatchTM. The license holder is Mylab Discovery S0lutions 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

HCV Ab Test

UID: MFG/IVD/2020/000021_bb35c69b8f76fa5749c56131e53bd4f6_136448321c863e937ddd205719ce6afd

Brand Name

PathoCatchTM

License Holder

Mylab Discovery S0lutions Pvt. Ltd

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

HCV is an in vitro immunochromatographic, rapid assay designed for the qualitative detection of antibodies specific to HCV, in human serum, plasma and capillary blood. HCV Ab test is intended for professional use as the initial test, as an aid to diagnosis. Reactive specimens should be reflexed for additional testing, either by nucleic acid testing (PathoCatchTM) technologies for the detection of HCV RNA or HCV core antigen testing, to identify current HCV infection. This product is intended for use in a population with high HCV prevalence or who have a history of HCV risk exposure/behavior including pregnant women. The performance of the assay has not been established for populations of infants or children

Class D

COVID-19 FIA Test Kit

Brand: PathoCatchTM

Mylab Discovery S0lutions Pvt. Ltd

Class D

Brand: Multigene-Multiplex Single tube format

Class C