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Panther Fusion® GI BACTERIAL CONTROLS, FUSION, IVD

by Hologic

Ref PRD-07116

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455DIAGPFGIBACUY Basic UDI-DI 15420045517493UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045517493 UDI-DI Date7 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Panther Fusion GI Bacterial Assay Controls Kit EUDAMED
Panther Fusion® GUDID
Generic Name
Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Model / Ref / Catalog
PRD-07116, GI BACTERIAL CONTROLS, FUSION, IVD
Primary DI / UDI-DI
15420045517493
Basic UDI-DI
54200455DIAGPFGIBACUY
Unit of Use DI
05420045517496
510(k) Number
FDA Product Code
PCH, OOI
EMDN Code
W0105080807 Multiconstituent controls - inf.imm.
GMDN Term
Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
866.3990, 862.2570
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PRD-07116
GUDID
GI BACTERIAL CONTROLS, FUSION, IVD
Device ClassEUDAMED
Class C
GUDID
Class II

Related devices

Cleared under the same submission (K251868)

Other devices from Hologic

See all devices from Hologic →

Properties

  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No