DermaGenius® Complete
- UID
- IMP/IVD/2023/000125_deea4ba262c808ead9cc0c786a7a8aaf_f2ae39588e26ae48a99f1191b20954ec
- Device class
- Class C
- Brand name
- DermaGenius Multiplex real-time PCR kit
- License holder
- ADT India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The DermaGenius® 2.0 Complete multiplex real-time PCR kit (DermaGenius Multiplex real-time PCR kit) is designed for detection of superficial fungal infections in nail, hair and skin material. The kit can detect the following nail, hair and skin pathogens: • Candida albicans (DermaGenius Multiplex real-time PCR kit); • Trichophyton interdigitale (DermaGenius Multiplex real-time PCR kit); • Trichophyton tonsurans (DermaGenius Multiplex real-time PCR kit); • Trichophyton mentagrophytes (DermaGenius Multiplex real-time PCR kit); • Trichophyton rubrum (DermaGenius Multiplex real-time PCR kit); • Trichophyton soudanense (DermaGenius Multiplex real-time PCR kit); • Trichophyton violaceum (DermaGenius Multiplex real-time PCR kit); • Trichophyton benhamiae (DermaGenius Multiplex real-time PCR kit); • Trichophyton verrucosum (DermaGenius Multiplex real-time PCR kit); • Microsporum canis (DermaGenius Multiplex real-time PCR kit); • Microsporum audouinii (DermaGenius Multiplex real-time PCR kit); • Epidermophyton floccosum (DermaGenius Multiplex real-time PCR kit)
DermaGenius® Complete is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000125_deea4ba262c808ead9cc0c786a7a8aaf_f2ae39588e26ae48a99f1191b20954ec. 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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