Diagnostics test reagent kits for SARS-CoV-2 Fluorescent PCR
- UID
- MFG/IVD/2022/000009_78ea67deaf51962ec4fd9eb86512a415_07bc163789a0f2c4aa4e7c8439b88a9a
- Device class
- Class C
- Brand name
- Covid-19 RT PCR
- License holder
- Vimek Bioconcept Pvt Ltd
- 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
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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