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

COVID-19 One-Step Multiplex RT-PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000033_d97bb453238335a55c1547ab8772aedb_4d3c34c090e2c2ddae72eacfb114921b. This device is marketed under the brand name BIOPRO. The license holder is Alchem Diagnostics, 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 One-Step Multiplex RT-PCR Kit

UID: MFG/IVD/2022/000033_d97bb453238335a55c1547ab8772aedb_4d3c34c090e2c2ddae72eacfb114921b

Brand Name

BIOPRO

License Holder

Alchem Diagnostics

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Biopro Covid 19 One step multiplex RT PCR Kit is a ready to use kit allowing reverse transcription and subsequent probe based multiplex PCR technology in a single tube that is intended for the identification and detection of novel Corona virus (BIOPRO) in respiratory specimens such as a nasopharyngeal swab, oropharyngeal swab, oropharyngeal wash, sputum, endotracheal aspirate, bronchoalveolar lavage and saliva samples. For In vitro diagnostic professional use only.

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Brand: Biopro

Class A