MERIDIAN BIOSCIENCE ISRAEL LTD

Address:4 HaMaayan St,Modiin Central,IL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (3) Test, Urea (Breath Or Blood) (MSQ) (3)

Premarket Exempt

No Yes

Clear

IDKIT: HP ONE - 00350402100137 Catalog Number :

Device Description : The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is us The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient.

Device Class :

Duns Number: 514832786

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

IDKIT: HP TWO - 00350402100144 Catalog Number :

Device Description : The IDkit Hp™ Two is a kit for the collection of exhaled breath from a test subj The IDkit Hp™ Two is a kit for the collection of exhaled breath from a test subject that needs to undergo H. pylori diagnosis and that the diagnosis is to be performed by means of the Urea Breath Test (UBT). The exhaled breath is collected into designated breath sample bags.Using the Breath Bags, IDkit: Hp™ Two, enables performing the analysis with the BreathID systems at a different location from the place of breath collection.

Device Class :

Duns Number: 514832786

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

BreathID Hp System - 07290016923056 Catalog Number : VS01000

Device Description : The BreathID® Hp System is intended for use to continually and non-invasively me The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach.The BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.

Device Class : 1

Duns Number: 514832786

Premarket Exempt : Yes

Product Code : MSQ, JJQ

Prescription Use : Yes

Device Count : 1

BreathID Hp Lab System - 07290016923070 Catalog Number :

Device Description : The BreathID® Hp Lab System is intended for use to non-invasively measure change The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application

Device Class : 1

Duns Number: 514832786

Premarket Exempt : No

Product Code : MSQ, JJQ

Prescription Use : Yes

Device Count : 1

BreathID Smart System - 07290016923223 Catalog Number :

Device Description : The BreathID® Smart System is intended for use to non-invasively measure changes The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.

Device Class : 1

Duns Number: 514832786

Premarket Exempt : No

Product Code : MSQ, JJQ

Prescription Use : Yes

Device Count : 1

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