Search Results

The BreathID® Hp System is intended for use to continually and 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 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. The device is for use by trained health care professionals. To be administered under a physician's supervision.

The BreathID® Hp System is a non-invasive breath test system for detecting the presence of Helicobacter pylori (H. pylori). The systems consist of an electro-optical medical device designed to measure and compute the changes in the ratio between 1302 and 1202 concentrations in the patient's exhalation, software, and a test kit. The IDkit Hp® One test kit consists of: - . One Package Insert - One Tablet of 13C-enriched urea,75mg . - One packet of 4.3g of Powder Citrica (citric acid). . - One IDcircuit™ nasal cannula ● - . One straw for stirring and drinking Using a nasal cannula for breath collection directly from the patient's nostrils enables point of care testing. The BreathID® Hp continually measures and computes the ratio between 13CO2 and 12CO2 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2/ 12CO2 ratio before and after ingestion of "3C-urea is used to compute the Delta over Baseline (DOB). The 13C measurement method is based on Molecular Correlation Spectroscopy™ (MCS) technology. MCS technology is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.

The BreathID® Hp Lab System or 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® Hp Lab System or BreathID® Smart 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. The BreathID® Smart System consists of the appropriate IDkit Hp® kit and the BreathID® Smart device. To be administered by trained personnel as ordered by a licensed healthcare practitioner.

The modified BreathID® Smart System, is a non-invasive breath test system for detecting the presence of Helicobacter pylori (H. pylori). The system consists of an electro-optical medical device with embedded software designed to measure and compute the changes in the ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, an integrated Auto Sampler, integrated software, and a test kit. The IDkit Hp® Two test kit consists of: - One 75mg 13C-urea tablet . - One packet of 4.3g of powdered Citrica (citric acid) . - One drinking straw ● - One drinking cup ● - One Package Insert (Instructions for Use) ● - One Quick User Guide ● - Two Breath Sample Bags (one Baseline and one Post Ingestion) ● - Four bar code labels . - A large Sample Transport Bag ● Using bags for breath collection enables off-site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The modified BreathID® Smart System measures and computes the ratio between 13CO2and 12CO2 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2ratio before and after ingestion of 13C-urea is used to compute the Delta over Baseline (DOB). The 13C measurement method for both the subject and the cleared (predicate) versions of the BreathID® Smart System is based on Molecular Correlation Spectroscopy™ (MCS) technology. MCS technology is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.

The BreathID Hp Lab System or 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 Hp Lab System or BreathID Smart 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 BreathD Hp Lab System consists of the appropriate IDkit Ho kit, and the BreathID Hp device, Auto Sampler and Lab Application. The BreathID Smart System consists of the appropriate IDkit Hp kit and the BreathID Smart device. To be administered by trained personnel as ordered by a licensed healthcare practitioner.

The BreathID® Hp Lab System and the BreathID® Smart System are two non-invasive breath test systems for detecting the presence of Helicobacter pylori (H. pylori) based on the same technology. The systems consist of an electro-optical medical device designed to measure and compute the changes in the ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, an Auto Sampler, software, and a test kit. The IDkit Hp™ Two test kit consists of: - One 75mg 13C-urea tablet . - One packet of 4.3g powdered Citrica (citric acid) . - One drinking straw . - One drinking cup . - One Package Insert (Instructions for Use) . - One Quick User Guide ● - Two Breath Sample Bags (one Baseline and one Post Ingestion) . - Four bar code labels ● - One large Sample Transport Bag ● Using bags for breath collection enables off-site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The BreathID® Hp Lab System and the BreathID® Smart System measure and compute the ratio between 13CO2 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2 ratio before and after ingestion of 13C-urea is used to compute the Delta over Baseline (DOB). The 13C measurement method is based on Molecular Correlation Spectroscopy™ (MCS) technology. MCS technology is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.