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HP IgA - India CDSCO Medical Device Registration

HP IgA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000842_6fdfdd4877cf5252b4cf9045f7f48ee3_afa87a77458617cc3d56735662986098. This device is marketed under the brand name HDV IgM. The license holder is Weldon Biotech India Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
HP IgA
UID: IMP/IVD/2020/000842_6fdfdd4877cf5252b4cf9045f7f48ee3_afa87a77458617cc3d56735662986098

Brand Name

HDV IgM

Device Class

Class B

Approving Authority

CDSCO

Product Information

This device HPA.CE is a quantitative/qualitative test to determinate IgA antibodies to Helicobacter pylori in human plasma and sera. The HPA.CE test can be used manually or automatically. The HPA.CE test is intended exclusively for in vitro diagnostic use

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