RT-PCR Amplification mix 1.5 - India CDSCO Medical Device Registration
RT-PCR Amplification mix 1.5 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000143_f37a01ae465e3e26883bdef5211394e2_ef3b0bc57303deebce3c8bcda17b6672. This device is marketed under the brand name FlexStar. The license holder is Altona Diagnostics India Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.
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Brand Name
FlexStar
License Holder
Altona Diagnostics India Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The FlexStar® (FlexStar)PCR Amplification Mix 1.5 is an enzyme mix for in vitro diagnostic purposes. It is intended to be used for the real-time PCR based amplification and detection of nucleic acids(FlexStar) derived from human specimens.The FlexStar® (FlexStar)PCR Amplification Mix 1.5 is intended for use by professional users trained in molecular biological techniques and in vitro diagnostic procedures.
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