Diagnostics test reagent kits for SARS-CoV-2 Fluorescent PCR - India CDSCO Medical Device Registration

Diagnostics test reagent kits for SARS-CoV-2 Fluorescent PCR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000009_78ea67deaf51962ec4fd9eb86512a415_07bc163789a0f2c4aa4e7c8439b88a9a. This device is marketed under the brand name Covid-19 RT PCR. The license holder is Vimek Bioconcept Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Diagnostics test reagent kits for SARS-CoV-2 Fluorescent PCR

UID: MFG/IVD/2022/000009_78ea67deaf51962ec4fd9eb86512a415_07bc163789a0f2c4aa4e7c8439b88a9a

Brand Name

Covid-19 RT PCR

License Holder

Vimek Bioconcept Pvt Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

For in vitro qualitative detection of SARS-CoV-2 ( Covid-19 RT PCR) in human oropharyngeal swabs or sputum pecimens by multiplex real-time reverse-transcription PCR method. It is mainly used for screening, diagnosis or differential diagnosis for SARS-CoV-2 infected cases or suspected cases