Novel Coronavirus RT- PCR Detection Kit - India CDSCO Medical Device Registration

Novel Coronavirus RT- PCR Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000170_2c7d95763bd70fc8d0691aa35d66679d_63e75b324d05f7f489be256e219209d4. This device is marketed under the brand name 2019-nCoV. The license holder is Gland Pharma Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Novel Coronavirus RT- PCR Detection Kit

UID: IMP/IVD/2020/000170_2c7d95763bd70fc8d0691aa35d66679d_63e75b324d05f7f489be256e219209d4

Brand Name

2019-nCoV

License Holder

Gland Pharma Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

This product is intended for the rapid detection of 2019-nCoV by TaqMan multiplex real-time PCR in human throat swab or sputum samples

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