SARS-Cov-2 Fluorescent PCR - India CDSCO Medical Device Registration
SARS-Cov-2 Fluorescent PCR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000319_5cdcd7da54c20073c56de91558d8d07a_7173ec337155f24dfda9beba245441d8. This device is marketed under the brand name Maccura. The license holder is Edif Medical Systems, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Maccura
License Holder
Edif Medical SystemsDevice Class
Approving Authority
CDSCO
Product Information
For in vitro qualitative detection of SARS-CoV-2 (Maccura) ORF1ab, E, and N gene in oropharyngeal swabs and sputum specimens of suspected SARS-CoV-2-infected pneumonia cases, suspected clustered infection cases, and others who need SARS-CoV-2 infection diagnosis or differential diagnosis.
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