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Alethia™ C. difficile 480050

by Meridian Bioscience Inc.

Alethia C. difficile 480050 is a clostridium difficile nucleic acid IVD (FDA Class I; FDA product code OMN, C. Difficile Nucleic Acid Amplification Test Assay) made by Meridian Bioscience Inc., listed in FDA GUDID since 9 Jan 2019 (UDI-DI 00840733102172), registry data as of 8 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840733102172 UDI-DI Date9 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Alethia™ C. difficile
Generic name
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
480050
Primary DI / UDI-DI
00840733102172
FDA product code
OMN
GMDN term
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class I
Regulation number
866.2660
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)