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Idkit: Hp Two AC00063

by Meridian Bioscience Israel Ltd

Idkit: Hp Two AC00063 is a carbon isotope breath test kit IVD made by Meridian Bioscience Israel Ltd, cleared under FDA 510(k) K193610 on 6 Feb 2020 (1 earlier submission) and listed in FDA GUDID since 15 Dec 2021 (UDI-DI 00350402100144), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00350402100144 UDI-DI Date15 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK193610 Date6 Feb 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193610 decided 6 Feb 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00350402100144 listed 15 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173777
  2. Cleared FDA 510(k) K193610
  3. Listed FDA GUDID 00350402100144

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Idkit: Hp Two
Generic name
Carbon isotope breath test kit IVD
Model / reference
AC00063
Primary DI / UDI-DI
00350402100144
510(k) Number
GMDN term
Carbon isotope breath test kit IVD
GUDID distribution status
In Commercial Distribution
Size
Height — 11.4 Centimeter
Length — 20 Centimeter
Width — 21 Centimeter

Related devices

Category: Carbon isotope breath test kit IVD

Cleared under the same submission (K173777)

Cleared under the same submission (K193610)

Other devices from Meridian Bioscience Israel Ltd.

See all devices from Meridian Bioscience Israel Ltd. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)