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

H.pylori Ab Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000106_f4063dff1c5d3c7207912008a6df0940_22f810f5c1bdb3be7981f788a14df964. This device is marketed under the brand name hCG. The license holder is Medlera Healthcare, and it is classified as Device Class Class B. The approving authority is Gujarat.

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.

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CDSCO Registered
Class Class B
H.pylori Ab Rapid Test
UID: MFG/IVD/2023/000106_f4063dff1c5d3c7207912008a6df0940_22f810f5c1bdb3be7981f788a14df964

Brand Name

hCG

License Holder

Medlera Healthcare

Device Class

Class B

Approving Authority

Gujarat

Product Information

The H. Pylori Ab Rapid test kit is a rapid immunochromatography assay for the qualitative detection of antibodies against Helicobacter pylori (hCG) in human serum or plasma samples. The test is intended as an aid in the diagnosis of H. pylori infection

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