STANDARD M10 C. difficile - India CDSCO Medical Device Registration

STANDARD M10 C. difficile is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000339_472a29bca1b6b92cce3e1baa2e68c29e_5c5ba48baf9b60445a1af30af2165e93. 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 C. difficile

UID: IMP/IVD/2023/000339_472a29bca1b6b92cce3e1baa2e68c29e_5c5ba48baf9b60445a1af30af2165e93

License Holder

SD Biosensor Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

STANDARD M10 C. difficile test is a multiplex Real-Time PCR test intended for use with STANDARD M10 system for the qualitative detection of viral DNA from Clostridium difficile (toxin B gene (NA)) in unformed (NA) stool specimens collected from patients with symptoms. Positive results are indicative of the presence of toxin B (NA) DNA; 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 C. difficile test is intended to be performed by trained users in both laboratories and near-patient testing settings.