Standard M10 Module - India CDSCO Medical Device Registration

Standard M10 Module is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000025_cf5ed5e9049229f521c759f2a99853b1_e4fa6fb03bc40b70ce8b7e26c167bd6c. This device is marketed under the brand name Standard G6PD Analyzer. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Standard M10 Module

UID: IMP/IVD/2021/000025_cf5ed5e9049229f521c759f2a99853b1_e4fa6fb03bc40b70ce8b7e26c167bd6c

Brand Name

Standard G6PD Analyzer

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

STANDARD M10 Console records the resulting fluorescence changes during amplification reactions over time. It performs qualitative detection or quantitative analysis of specific targets through the algorithm. After checking the validity based on the information read from the 2D barcode, it displays the result value. The result value is displayed on the M10 Console screen and stored in the memory of the M10 Console