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

One Step RT-PCR Kit for Covid-19 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000158_aef867f8e37f01c1b63606a9fa495c7e_1c23fc2d90723e63c279aa02f8d38b2b. This device is marketed under the brand name AXIBIO. The license holder is Axiva Sichem Biotech, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered
Class Class C
One Step RT-PCR Kit for Covid-19
UID: MFG/IVD/2020/000158_aef867f8e37f01c1b63606a9fa495c7e_1c23fc2d90723e63c279aa02f8d38b2b

Brand Name

AXIBIO

License Holder

Axiva Sichem Biotech

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

AxiBio One Step RT-PCR Kit provides an easy and fast method for amplification of clinical samples of covid-19. Corona Virus are enveloped with single stranded RNA genome and Nucleocapsid with the characteristic club shaped spikes on the surface. It is highly diverse because of mutation and recombination. In response to covid-19 outbreak AxiBio has developed a multiplex RT-PCR.

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