Smart Detect SARS-CoV-2 rRT-PCR Kit - India CDSCO Medical Device Registration

Smart Detect SARS-CoV-2 rRT-PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000145_7ddbc99abf0c24b0e9068919722187eb_8ab16aa191cbe89891c33ccf4c0050d9. This device is marketed under the brand name SCoV-2 DetectTM IgM ELISA. The license holder is SIRUS BIOCARE 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

Smart Detect SARS-CoV-2 rRT-PCR Kit

UID: IMP/IVD/2019/000145_7ddbc99abf0c24b0e9068919722187eb_8ab16aa191cbe89891c33ccf4c0050d9

Brand Name

SCoV-2 DetectTM IgM ELISA

License Holder

SIRUS BIOCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

Smart DetectTM SARS-CoV-2 rRT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome-related coronavirus 2 (SCoV-2 DetectTM IgM ELISA) in human nasopharyngeal swab, anterior nasal swab and mid-turbinate nasal swab specimens