Pure Global

Uncut Sheet of STANDARD F H. pylori Ag FIA - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class C
Uncut Sheet of STANDARD F H. pylori Ag FIA
UID: IMP/IVD/2021/000025_ddde828d64c809b730bb19b42cfc3941_094d74a8e1002cd56745e11a75976faf

Brand Name

Bulk

Device Class

Class C

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

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing