Sensit Adenovirus and Rotavirus Combo Test Kit - India CDSCO Medical Device Registration

Sensit Adenovirus and Rotavirus Combo Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000095_2440dc97e0b4c7cdb3687114867596b8_809443451f04ed34566eeb32c28010f1. This device is marketed under the brand name Sensit Rapid. The license holder is Ubio Biotechnology Systems Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

Sensit Adenovirus and Rotavirus Combo Test Kit

UID: MFG/IVD/2020/000095_2440dc97e0b4c7cdb3687114867596b8_809443451f04ed34566eeb32c28010f1

Brand Name

Sensit Rapid

License Holder

Ubio Biotechnology Systems Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Sensit Adenovirus and Rotavirus Combo Test is a rapid and convenient immunochromatographic assay for the qualitative detection of adenovirus and/or rotavirus in human fecal samples. It is intended for professional use as an aid in the diagnosis of rotavirus and /or adenovirus-associated gastroenteritis. This assay provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test