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CDSCO UID MFG/IVD/2022/000084_2af313680b047db55ec83a25d59d44d1_378a0635fa92d4f7f5d048294913f0df

H. pylori Rapid Test Device

Medinova Endosys·Device Class Class C·India CDSCO·Brand: EndoXpert
Registration details
UID
MFG/IVD/2022/000084_2af313680b047db55ec83a25d59d44d1_378a0635fa92d4f7f5d048294913f0df
Device class
Class C
Brand name
EndoXpert
License holder
Medinova Endosys
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.
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About this record

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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