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Quidel Molecular M108

by Diagnostic Hybrids, Inc.

Ref M108Model Quidel

Quidel Molecular M108 is a device classified as IVD General (EU), Class I (US) made by Diagnostic Hybrids, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-30014613311089) and listed in FDA GUDID since 16 Nov 2018 (UDI-DI 30014613311089), 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-30014613311089 Basic UDI-DI 30014613311089UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613311089 UDI-DI Date16 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613311089 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 30014613311089 listed 16 Nov 2018 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 30014613311089
  2. Registered EUDAMED B-30014613311089

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  • Withdrawn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
Quidel Molecular C. difficile Control Set EUDAMED
Quidel Molecular GUDID
Generic name
Clostridium difficile nucleic acid IVD, control
Device name
Molecular C. difficile Control Set
Model / Ref / Catalog
M108, Quidel
Primary DI / UDI-DI
30014613311089
Basic UDI-DI
B-30014613311089
FDA product code
JJX
EMDN code
W0105011402 Campylobacter detection by na reagents
GMDN term
Clostridium difficile nucleic acid IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I 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, control

Similar devices in this category

Other devices filed under CAMPYLOBACTER DETECTION BY NA REAGENTS.

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

  • Single use
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)