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AmpliVue C. difficile Assay

by Quidel Corp.

AmpliVue C. difficile Assay (M201) is a Class II device made by Quidel Corp., listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613312017), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30014613312017 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
AmpliVue
Generic name
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
C. difficile Assay, M201
Primary DI / UDI-DI
30014613312017
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
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code OZN (C.Difficile toxin gene amplification assay).

Other devices from Quidel Corp.

See all devices from Quidel Corp. →

Properties

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