UTI Antimicrobial Susceptibility Testing PCR Kit - India CDSCO Medical Device Registration
UTI Antimicrobial Susceptibility Testing PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2018/000002_d2046e1c156001d528dfcbd056ebe467_0f6abca534630dc11cc8c6b1930767a6. 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
TRUPCR® UTI AST Panel Kit is an in vitro nucleic acid amplification assay for the detection & differentiation of antimicrobial resistance genes encoding resistance to antibiotics- Trimethoprim/Sulfamethoxazole (TRUPCR® MPN Panel Kit), Extended-spectrum beta-lactams (TRUPCR® MPN Panel Kit), Carbapenems, Vancomycin and Methicillin in uropathogens present in human urine of UTI infected individuals using Real Time PCR System. The results from the TRUPCR® UTI AST panel 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. This kit can be used directly with the pre-processed urine sample, isolated uropathogen(TRUPCR® MPN Panel Kit) or using its extracted genomic DNA
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