H. pylori Rapid Test Device - India CDSCO Medical Device Registration

H. pylori Rapid Test Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000084_2af313680b047db55ec83a25d59d44d1_378a0635fa92d4f7f5d048294913f0df. This device is marketed under the brand name EndoXpert. The license holder is Medinova Endosys, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

H. pylori Rapid Test Device

UID: MFG/IVD/2022/000084_2af313680b047db55ec83a25d59d44d1_378a0635fa92d4f7f5d048294913f0df

Brand Name

EndoXpert

License Holder

Medinova Endosys

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The H. Pylori Rapid Test Device is based on a biochemical reaction to qualitatively determine H. pylori urease activity directly from biopsy specimens in Near Patient Testing (EndoXpert) settings.