STANDARD M10 MDR-TB - India CDSCO Medical Device Registration

STANDARD M10 MDR-TB is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000339_74bd7c7b26ceacd37e4101561aab2aee_81bac9ab1913e0d5b060514a7b7b4a8b. 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 MDR-TB

UID: IMP/IVD/2023/000339_74bd7c7b26ceacd37e4101561aab2aee_81bac9ab1913e0d5b060514a7b7b4a8b

License Holder

SD Biosensor Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

STANDARD M10 MDR-TB is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of M. tuberculosis nucleic acids and drug-resistance mutation in human normal sputum or sputum sediment sample. Positive results of IS1081 and IS6110 are indicative of the presence of M. tuberculosis. Positive results for rpoB, katG and inhA indicate that the detected M.tuberculosis have drug resistance for rifampicin (NA) and/or isoniazid (NA). Determining a patient's infection status requires clinical correlation with the patient's medical history and other diagnostic information. 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 MDR-TB is intended to be performed by trained users in both laboratory and near patient testing setting