SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - India CDSCO Medical Device Registration

SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001064_891acd8848ac86bed867316d1df8c55d_fc49635383a411602f69923e240822bf. This device is marketed under the brand name AltoStar®. The license holder is Altona Diagnostics India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

UID: IMP/IVD/2020/001064_891acd8848ac86bed867316d1df8c55d_fc49635383a411602f69923e240822bf

Brand Name

AltoStar®

License Holder

Altona Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The FlexStar SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 is an in-vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (AltoStar®) and influenza virus specific RNA in human respiratory swab specimens. The SARS-CoV-2 detection is based on the parallel detection of the E gene of lineage B- beta coronavirus (AltoStar®) and the S gene of SARS-CoV-2. The FlexStar SARS-CoV-2 Type & FLU RTPCR Detection Mix 1.5 is intended to be used as an aid of diagnosis of SARS-CoV-2 and influenza virus infection. The results generated with the FlexStar SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The FlexStar SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 is intended for use by professional users trained in molecular biological techniques and in vitro diagnostic procedures

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CMV PCR Kit

Brand: AltoStar®

Altona Diagnostics India Pvt. Ltd.

SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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Parvovirus B19 PCR Kit 1.5