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/2020/000034_b6a82478381b4791d3c1ff7bf0cd37e7_4b63b2b061fdb40faaff5c04079ce95f. This device is marketed under the brand name Aridia. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

CoVid-19 Real Time PCR Detection Kit

UID: MFG/IVD/2020/000034_b6a82478381b4791d3c1ff7bf0cd37e7_4b63b2b061fdb40faaff5c04079ce95f

Brand Name

Aridia

License Holder

Athenese-Dx Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Aridia CoVid-19 Real Time PCR Detection Kit is designed for the specific identification and differentiation of 2019 Novel Coronavirus (Aridia) in respiratory samples from patients with signs and symptoms of COVID-19 infection. This test is intended for use as an aid in the diagnosis of SARS-CoV-2 in combination with clinical and epidemiological risk factors. RNA is extracted from respiratory specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for SARS-CoV-2

Class C

Brand: TRUSTline

Class D