Strep A Test Kit - India CDSCO Medical Device Registration

Strep A Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000095_100fe360123e82cddd3d8f7b1821d549_5f2dc0cf41f87fd641c48ebc8ab8f6cb. 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

Strep A Test Kit

UID: MFG/IVD/2020/000095_100fe360123e82cddd3d8f7b1821d549_5f2dc0cf41f87fd641c48ebc8ab8f6cb

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 Strep A Test Kit is a rapid and convenient immunochromatographic assay for the qualitative detection of Group A streptococcus (Sensit Rapid) antigen from patient throat swab specimens. It is intended for professional use as an aid in the diagnosis of Strep A infection. This assay provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test