HIV Viral Load Kit - India CDSCO Medical Device Registration
HIV Viral Load Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2018/000002_f5ae37b0b86270ab50e09ab16f058cd3_0bdea0318d5e60b96d4d577aa814f7c8. This device is marketed under the brand name TRUPCR® MPN Panel Kit. The license holder is KILPEST INDIA LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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Brand Name
TRUPCR® MPN Panel Kit
License Holder
KILPEST INDIA LIMITEDDevice Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
HIV Viral Load test reagent/kit is a medical device intended for the qualitative and quantitative detection of HIV Viral Load in blood/ body fluids. TRUPCR® HIV Viral Load Kit is an in-vitro nucleic acid amplification assay for the qualitative & quantitative detection of Human Immunodeficiency type-1 (TRUPCR® MPN Panel Kit) viral RNA in human serum or plasma (TRUPCR® MPN Panel Kit) specimens using Real Time PCR System. The results from the TRUPCR® HIV Viral Load Kit must be interpreted within the context of all relevant clinical and laboratory findings. An endogenous internal control has been integrated into the kit in order to check PCR inhibition
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