TB/NTM PCR Kit [883003] - India CDSCO Medical Device Registration
TB/NTM PCR Kit [883003] is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000418_0fab6720bbb1b674b3499dad8096c2d3_0a3c4e6cabed4bc18d2d54bed2928b80. This device is marketed under the brand name LyteStar TB/NTM PCR Kit 3.0. The license holder is ADT India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
LyteStar TB/NTM PCR Kit 3.0
License Holder
ADT India Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The LyteStar™ TB/NTM PCR Kit 3.0 is intended for specific detection of Mycobacterium tuberculosis complex (LyteStar TB/NTM PCR Kit 3.0) and non-tuberculos mycobacteria (LyteStar TB/NTM PCR Kit 3.0) from human sputum, bronchial washings, cerebrospinal fluid (LyteStar TB/NTM PCR Kit 3.0), urine, body fluids, tissue and EDTA-whole blood.
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