CDSCO UID IMP/IVD/2021/000025_ddde828d64c809b730bb19b42cfc3941_094d74a8e1002cd56745e11a75976faf

Uncut Sheet of STANDARD F H. pylori Ag FIA

SD Biosensor Healthcare Private Limited·Device Class Class C·India CDSCO·Brand: Bulk
Registration details
UID
IMP/IVD/2021/000025_ddde828d64c809b730bb19b42cfc3941_094d74a8e1002cd56745e11a75976faf
Device class
Class C
Brand name
Bulk
Approving authority
CDSCO
Product information
STANDARD F H. pylori Ag FIA is a qualitative immunoassay to detect H. pylori Ag in the human fecal specimen. The test is for in vitro diagnostic use and is intended as an aid to early diagnosis of H. pylori Ag infection. This is intended for professional use, only for an initial screening test
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About this record

Uncut Sheet of STANDARD F H. pylori Ag FIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000025_ddde828d64c809b730bb19b42cfc3941_094d74a8e1002cd56745e11a75976faf. This device is marketed under the brand name Bulk. The license holder is SD Biosensor Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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