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Revogene C. difficile 410300

by Meridian Bioscience Inc.

Revogene C. difficile 410300 (401300) is a clostridium difficile nucleic acid IVD (FDA Class II; FDA product code OZN, C. Difficile Toxin Gene Amplification Assay) made by Meridian Bioscience Inc., cleared under FDA 510(k) K172569 on 22 Nov 2017 and listed in FDA GUDID since 15 Jul 2020 (UDI-DI 00840733102349), active as of 8 Nov 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K172569

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840733102349 UDI-DI Date15 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172569 Date22 Nov 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172569 decided 22 Nov 2017 Active
  • FDA GUDID UDI-DI 00840733102349 listed 15 Jul 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1019-2026 FDA Class II initiated 5 Dec 2025

    The affected lots show a decline in performance over time, which may lead to false-negative results.

Timeline

3 dated events

  1. Cleared FDA 510(k) K172569
  2. Listed FDA GUDID 00840733102349
  3. Recall initiated FDA recalls Z-1019-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Revogene C. difficile
Generic name
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
410300, 401300
Primary DI / UDI-DI
00840733102349
510(k) Number
FDA product code
OZN
GMDN term
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class II
Regulation number
866.3130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Other devices from Meridian Bioscience Inc.

See all devices from Meridian Bioscience Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)