COVID-19 real-time PCR kit - India CDSCO Medical Device Registration

COVID-19 real-time PCR kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000392_4ce774d5a7f7a4f825171ebee3b47a88_e78ab989e1f354089300bc68d15954b7. This device is marketed under the brand name NuActor. The license holder is HORIBA INDIA 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

COVID-19 real-time PCR kit

UID: IMP/IVD/2020/000392_4ce774d5a7f7a4f825171ebee3b47a88_e78ab989e1f354089300bc68d15954b7

Brand Name

NuActor

License Holder

HORIBA INDIA Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

ExAmplar COVID-19 real-time PCR kit (NuActor) is a kit for the in vitro qualitative detection of SARS-CoV-2 responsible for COVID-19 in respiratory specimens. The primer and probe sets are designed for the universal detection of betacoronaviruses (NuActor) and for specific detection of COVID-19 (NuActor). For in vitro diagnostic use only.