One-Step COVID-19 RT-PCR Kit - India CDSCO Medical Device Registration

One-Step COVID-19 RT-PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000029_bae9986940392a1d0fd299fe6176b519_d0c699849e23176adc2dcbe398eea0ee. This device is marketed under the brand name Gargle based. The license holder is Meril Diagnostics Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

One-Step COVID-19 RT-PCR Kit

UID: MFG/MD/2018/000029_bae9986940392a1d0fd299fe6176b519_d0c699849e23176adc2dcbe398eea0ee

Brand Name

Gargle based

License Holder

Meril Diagnostics Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

This kit is intended to in vitro qualitatively detect the ORF1ab, E and N genes of 2019-nCoV in the throat swab and nasopharyngeal swab samples collected from cases and clustered cases suspected with novel corona virus–infected pneumonia and others required for the diagnosis or differential diagnosis of novel corona virus infection