IDkit HP ONE
citric acid anhydrous and 13C urea
Meridian Bioscience Israel Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005772418 | 3005772418 | Meridian Bioscience Israel Ltd. | 1 | N | 2026-01-01 | 4 HaMaayan St Modiin Central IL 7177872 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 66916 | 1286263714 | K223185 | BreathID® Smart System | MSQ | 2022-11-10 |
| 66916 | 1550499612 | K221896 | BreathID Hp System | MSQ | 2022-12-19 |
| 66916 | 1072565205 | K220494 | BreathID Hp Lab System, BreathID Smart System | MSQ | 2022-06-23 |
| 66916 | 1848117867 | K193610 | BreathID Smart System | MSQ | 2020-02-06 |
| 66916 | 1227449402 | K173777 | BreathID Hp Lab System | MSQ | 2018-03-08 |
| 66916 | 1700466300 | K173772 | BreathID Hp System | MSQ | 2018-03-08 |
| 66916 | 1407031780 | K162150 | BreathID Hp Lab System | MSQ | 2016-10-31 |
| 66916 | 1715184230 | K130524 | BREATHID HP SYSTEM | MSQ | 2013-05-22 |
| 66916 | 2035353983 | K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI | MSQ | 2001-07-09 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MSQ | 10 | 2022-12-19 |
NDC#
PMN#
BreathID Hp System
Meridian Bioscience Israel , Ltd.
BreathID® Smart System
Meridian Bioscience Israel Ltd.
BreathID Hp Lab System, BreathID Smart System
Meridian Bioscience Israel Ltd.
GUDID#
Auto Sampler (for BreathID Hp Lab System) - 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
2024-07-22
BreathID Hp Lab Device - 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
2024-07-22
BreathID Hp Lab Device (WIN) - 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
2024-07-22
BreathID Hp System - 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.
2023-04-11
BreathID Hp Lab System refurbished - 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
2023-04-11
BreathID Smart System refurbished - 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.
2023-04-11
BreathID Smart System - 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.
2023-04-11
IDKIT: HP TWO - 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.
2021-12-15
BreathID Smart System - 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.
2023-04-11
BreathID Hp System - 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.
2021-12-15
BreathID Hp Lab System - 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
2021-12-15
BreathID Smart System - 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.
2021-12-15
IDKIT: HP ONE - The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient.
2021-12-15
IDKIT: HP TWO - 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.
2021-12-15