HIV 1/2 Ab Test - India CDSCO Medical Device Registration

HIV 1/2 Ab Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_d1ad8e75938caf0d7f4e1c262bd82563_ce44b8b4bfd3620c2955833d6c442a81. 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

HIV 1/2 Ab Test

UID: MFG/IVD/2020/000021_d1ad8e75938caf0d7f4e1c262bd82563_ce44b8b4bfd3620c2955833d6c442a81

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

HIV 1/2 Ab Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies specific to HIV-1 and HIV 2 in human serum, plasma or venous whole blood or capillary blood. The test is for in vitro diagnostic use and intended as an aid to diagnosis of HIV in symptomatic, asymptomatic populations and persons at risk of HIV infection. The test is not intended for use on neonates or infants below 2 years. The test is intended to be used by trained healthcare or laboratory professionals or other health care workers who have received appropriate training. The product is not for blood donor screening. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of HIV Virus infection

Class D

Brand: Multigene-Multiplex Single tube format

Class C