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Panther Fusion®

by Hologic United States EUDAMEDGUDID

Ref PRD-07113 Product code PCHEMDN W0105070504

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455DIAGPFGIBACUY Basic UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045517486 UDI-DIDate7 Oct 2025ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 25 Oct 2026

Trade Name
Panther Fusion GI Bacterial Assay EUDAMED
Panther Fusion® GUDID
Generic Name
Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
PRD-07113, GI BAC REAGENT CARTRIDGES, 96-TEST, FUSION, IVD
Primary DI / UDI-DI
15420045517486
Basic UDI-DI
54200455DIAGPFGIBACUY
Unit of Use DI
05420045517489
510(k) Number
FDA Product Code
PCH, OOI
EMDN Code
W0105070504 Gastrointestinal infections - multiplex na reagents
GMDN Term
Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
866.3990, 862.2570
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PRD-07113
GUDID
GI BAC REAGENT CARTRIDGES, 96-TEST, 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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • FDA UDI e0f63365-db49-44a1-a552-cdeb41e7e221 37 fields · synced 25 Oct 2026
  • EUDAMED 15420045517486|54200455DIAGPFGIBACUY 61 fields · synced 25 Oct 2026