Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005772418

FEI Number

3005772418

Entity Name

Meridian Bioscience Israel Ltd.

City/State/Country

Modiin Central, IL

Establishment Address

4 HaMaayan St, Modiin Central 7177872, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Meridian Bioscience Israel Ltd. (Owner Number: 9088923)

Owner / Operator Contact Address

4 HaMaayan St, --, Modiin, IL-M 7177872, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173777

PMA Number

N/A

All Registered Proprietary Names

Breathid Hp System BreathID Hp Lab System BreathID Hp Lab System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2023-03-19
MSQ	Test, Urea (Breath Or Blood)	Microbiology	Class 1	866.3110	2023-03-19
MSQ	Test, Urea (Breath Or Blood)	Microbiology	Class 1	866.3110	2017-10-11
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2017-10-11
MSQ	Test, Urea (Breath Or Blood)	Microbiology	Class 1	866.3110	2018-10-08
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2018-10-08

Official Correspondent

Raffi Werner

US Agent Details

Susan Bogar Business: Meridian Bioscience Email: susan.bogar@meridianbioscience.com Phone: (513) 2713700

Related Public Records

Same Entity

Meridian Bioscience Israel Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2012	Exalenz Bioscience Ltd Hamaayan 4 Modiin Israel	1	IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.
Z-0003-2008	Meretek Diagnostics, Inc.	1	BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.

Similar Registrations

Registration Number	Establishment Name	Location
3011394152	Vigilant Biosciences Inc.	Lakeway, TX, US
3017132875	BEIJING SPIRITLASER SCIENCE & TECHNOLOGY CO., LTD.	Beijing, CN
3010399798	Innokas Medical Estonia Ou	Tallinn Harjumaa, EE
3008249922	BIOMERIEUX SA - Grenoble	Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR
9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005772418. Last updated year: 2026. Please use registration number 3005772418 when referencing this establishment in official correspondence.