PneumoGenius® Multiplex real-time PCR kit - India CDSCO Medical Device Registration

PneumoGenius® Multiplex real-time PCR kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000125_390be9694ad759e851af2aaf973d0c81_a88d7ab350e53f8e0e559c5d4e5c0501. 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

PneumoGenius® Multiplex real-time PCR kit

UID: IMP/IVD/2023/000125_390be9694ad759e851af2aaf973d0c81_a88d7ab350e53f8e0e559c5d4e5c0501

Brand Name

DermaGenius Multiplex real-time PCR kit

License Holder

ADT India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

PneumoGenius® is a multiplex real-time PCR assay that detects Pneumocystis jirovecii in respiratory tract samples within 2.5 hours. Pneumocystis jirovecii is a common cause of life-threatening pneumonia in immunocompromised patients