CDSCO UID MFG/IVD/2022/000033_d97bb453238335a55c1547ab8772aedb_4d3c34c090e2c2ddae72eacfb114921b

COVID-19 One-Step Multiplex RT-PCR Kit

Alchem Diagnostics·Device Class Class C·India CDSCO·Brand: BIOPRO
Registration details
UID
MFG/IVD/2022/000033_d97bb453238335a55c1547ab8772aedb_4d3c34c090e2c2ddae72eacfb114921b
Device class
Class C
Brand name
BIOPRO
License holder
Alchem Diagnostics
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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About this record

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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