AsperGenius® 2.0 Species - India CDSCO Medical Device Registration

AsperGenius® 2.0 Species is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000125_a548a92120694ce20ef05a75c030edc7_ebc405951ea286c60b6a12e938756a26. This device is marketed under the brand name DermaGenius Multiplex real-time PCR kit. The license holder is ADT India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

AsperGenius® 2.0 Species

UID: IMP/IVD/2023/000125_a548a92120694ce20ef05a75c030edc7_ebc405951ea286c60b6a12e938756a26

Brand Name

DermaGenius Multiplex real-time PCR kit

License Holder

ADT India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

It rapidly diagnoses Aspergillus infections. Within 2,5 hours, detection and characterization is accomplished in lower respiratory tract samples of Aspergillus infected patients.