AsperGenius® 2.0 Resistance - India CDSCO Medical Device Registration

AsperGenius® 2.0 Resistance is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000125_415b2f7c585ef2ba0bfd9cc4dc5c1fff_9c99c68cfef4699bd3fd01a5abac346b. 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 Resistance

UID: IMP/IVD/2023/000125_415b2f7c585ef2ba0bfd9cc4dc5c1fff_9c99c68cfef4699bd3fd01a5abac346b

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 and simultaneously identifies azole resistance. Within 2,5 hours, detection and characterization is accomplished in lower respiratory tract samples of Aspergillus infected patients