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Idkit: Hp Two

FDA UDI

by Meridian Bioscience Israel Ltd

Identity

Trade Name
IDKIT: HP TWO FDA UDI
Generic Name
Carbon isotope breath test kit IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
AC00063 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00350402100144 FDA UDI
510(k) Number
K173777 FDA UDI
K193610 FDA UDI
GMDN Term
Carbon isotope breath test kit IVD FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 11.4 Centimeter FDA UDI
Length — 20 Centimeter FDA UDI
Width — 21 Centimeter FDA UDI

Category: Carbon isotope breath test kit IVD

Idkit: Hp Two by Meridian Bioscience Israel Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carbon isotope breath test kit IVD.

Cleared under the same submission

K173777 also covers:

K193610 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience Israel Ltd

Sources (1)

  • FDA UDI 4eb1e558-cafc-4dc2-92b7-a3b5b33fcec2 36 fields · synced May 31, 2026