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STANDARD™ M10 SARS-COV-2 - India CDSCO Medical Device Registration

STANDARD™ M10 SARS-COV-2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000339_ba05b71f7ed75e34b30eb7228ffb2041_24ec186a787fd07ba092507116304807. The license holder is SD Biosensor Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
STANDARD™ M10 SARS-COV-2
UID: IMP/IVD/2023/000339_ba05b71f7ed75e34b30eb7228ffb2041_24ec186a787fd07ba092507116304807

Device Class

Class C

Approving Authority

CDSCO

Product Information

The STANDARD M10 SARS-CoV-2 test is a multiplex real-time RT-PCR test intended for use with STANDARD™ M10 system for the qualitative detection of nucleic acids from SARS-CoV-2 in upper respiratory specimens (NA) collected from individuals suspected of COVID-19 by their healthcare provider

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