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.


Product Overview

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.
IDKIT: HP TWO - AC00063


Device Description

A collection of devices intended to be used for carbon-13 breath analysis to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon-13 labelled substrate and breath specimen containers. The test relies on the metabolism of the substrate and expiration of carbon-13 isotopes in CO2. It can be administered by a healthcare professional in a clinical setting and alternatively by the patient at home; the collected expired breath sample is analysed by an infrared or mass spectrometry analyser (not included) in a clinical laboratory or at the point-of-care. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 25.00
    • 20.00
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 20.00

  • Device Sizes

  • Height: 11.4 Centimeter
  • Length: 20 Centimeter
  • Width: 21 Centimeter
    • Height: 11.4 Centimeter
    • Length: 20 Centimeter
    • Width: 21 Centimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    No Data Available

    Device Identifiers

    Device Id: 20350402100148

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00350402100144

    Package Quantity: 20

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Box


    Device Id: 00350402100144

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 40350402100142

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00350402100144

    Package Quantity: 160

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Pallet


    Device Id: 50350402100149

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00350402100144

    Package Quantity: 240

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Pallet


    Device Id: 90350402100147

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00350402100144

    Package Quantity: 400

    Package Discontinue Date: 3/19/2023 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Pallet


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