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COVID-19 Real Time PCR Detection Kit - India CDSCO Medical Device Registration

COVID-19 Real Time PCR Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000136_715cff8e4f231d7ef48784c40f51d6db_12290f0c5697ff136ca3349fc987954f. This device is marketed under the brand name ErbaMDx COVID-19 RT-PCR Kit. The license holder is Transasia Diagnostics Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered
Class Class C
COVID-19 Real Time PCR Detection Kit
UID: MFG/IVD/2021/000136_715cff8e4f231d7ef48784c40f51d6db_12290f0c5697ff136ca3349fc987954f

Brand Name

ErbaMDx COVID-19 RT-PCR Kit

Device Class

Class C

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

Erba MDx COVID-19 RT-PCR Kit is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in samples collected from patients with a clinical suspicion and/or signs and symptoms suggestive of COVID-19 infection. Results are for the detection of SARS-CoV-2 RNA in nasopharyngeal & oropharyngeal swab samples during suspected COVID-19 infection, as an aid to diagnosis.

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