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Lyra Direct C. difficile Assay

by Quidel Corp.

Ref M105Model Lyra

Lyra Direct C. difficile Assay (M105) is a clostridium difficile nucleic acid IVD (EU IVDD general IVD; FDA Class II) made by Quidel Corp., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-30014613311058) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613311058), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613311058 Basic UDI-DI 30014613311058UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613311058 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613311058 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 30014613311058 listed 15 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 30014613311058
  2. Registered EUDAMED B-30014613311058

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Lyra Direct C. difficile Assay EUDAMED
Lyra GUDID
Generic name
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Device name
Direct C. difficile Assay
Model / Ref / Catalog
Lyra, M105, Direct C. difficile Assay
Primary DI / UDI-DI
30014613311058
Basic UDI-DI
B-30014613311058
FDA product code
OZN, OOI
EMDN code
W0105011402 Campylobacter detection by na reagents
GMDN term
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.3130, 862.2570
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Lyra
M105
GUDID
Direct C. difficile Assay
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

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

Similar devices in this category

Other devices filed under CAMPYLOBACTER DETECTION BY NA REAGENTS.

Other devices from Quidel Corp.

See all devices from Quidel Corp. →

Properties

  • Single use
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)