Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test - UK MHRA Medical Device Registration

Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 95819. The device is manufactured by Meridian Bioscience Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Launch Diagnostics Limited.

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In Vitro Diagnostic Device

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Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

MHRA Device ID: 95819•Ref: 95819

Device Type

In Vitro Diagnostic Device

Devices

Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Sep 10, 2024

Manufacturer Information

Name

Meridian Bioscience Inc.

Address

3471 River Hills Drive

Cincinnati, OH, United States

Created Date

Aug 18, 2021

Authorized Representative

Name

Launch Diagnostics Limited

Relationship Type

UK Responsible Person

Address

Unit 20 Ash Way Thorp Arch Estate

Wetherby, England, United Kingdom

Postcode: LS23 7FA

DJ Fang

MedTech Regulatory Expert

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Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test - UK MHRA Medical Device Registration

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Date Registered

Last Updated

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Created Date

Name

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Address

DJ Fang

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