Strep A Test Kit
- UID
- MFG/IVD/2020/000095_100fe360123e82cddd3d8f7b1821d549_5f2dc0cf41f87fd641c48ebc8ab8f6cb
- Device class
- Class C
- Brand name
- Sensit Rapid
- License holder
- Ubio Biotechnology Systems Private Limited
- 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
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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