CDSCO UID IMP/IVD/2023/000339_472a29bca1b6b92cce3e1baa2e68c29e_5c5ba48baf9b60445a1af30af2165e93
STANDARD M10 C. difficile
SD Biosensor Healthcare Private Limited·Device Class Class C·India CDSCO
Registration details
- UID
- IMP/IVD/2023/000339_472a29bca1b6b92cce3e1baa2e68c29e_5c5ba48baf9b60445a1af30af2165e93
- Device class
- Class C
- License holder
- SD Biosensor Healthcare Private Limited
- 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.
Other products from SD Biosensor Healthcare Private Limited
Products from the same license holder (10 products)
Safety lancet
Brand: ULTRA Safe-T Lancet
Class B
Safety Lancet
Brand: Ultra
Class B
Blood Lancet
Brand: Ultra
Class B
STANDARD M10 MTB/NTM
Class C
STANDARD™ M10 SARS-COV-2
Class C
STANDARD M10 Stool Pretreatment kit
Class B
STANDARD M10 Sputum Pretreatment Kit
Class B
STANDARD M10 MDR-TB
Class C
Calibration Kit
Class B
Uncut sheet of STANDARD F beta-HCG FIA
Brand: Extraction Buffer Solution of STANDARD F T4
Class B
About this record
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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.