STANDARD M10 MTB/NTM - India CDSCO Medical Device Registration

STANDARD M10 MTB/NTM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000339_bec16b425f015ed22a5384976290e4d1_d165d5ab0a94d6b6c4cb5a5a623a4295. The license holder is SD Biosensor Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

STANDARD M10 MTB/NTM

UID: IMP/IVD/2023/000339_bec16b425f015ed22a5384976290e4d1_d165d5ab0a94d6b6c4cb5a5a623a4295

License Holder

SD Biosensor Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

STANDARD M10 MTB/NTM is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of M. tuberculosis, and non-tuberculous mycobacteria (NA) nucleic acids in human normal sputum or sputum sediment sample. Positive results are indicative of the presence of M. tuberculosis, and/or NTM; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Negative results should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. STANDARD M10 MTB/NTM is intended to be performed by trained users in both laboratory and near patient testing setting