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TB/NTM PCR Kit [883003W/E] - India CDSCO Medical Device Registration

TB/NTM PCR Kit [883003W/E] is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000418_1bc5deda6f8c4bf7798a181a74436511_f299c2816cadb9d352da5d19c2e73fc5. 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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CDSCO Registered
Class Class C
TB/NTM PCR Kit [883003W/E]
UID: IMP/IVD/2021/000418_1bc5deda6f8c4bf7798a181a74436511_f299c2816cadb9d352da5d19c2e73fc5

Brand Name

LyteStar TB/NTM PCR Kit 3.0

License Holder

ADT India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LyteStarโ„ข 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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