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Staphytect Plus

by Oxoid Ltd 2 variants

Ref DR0850B

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5032384StaphytectPlusNH Basic UDI-DI 05032384029051UDI-DIDate6 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384029051 UDI-DI Date28 Jan 2026ListedStatusListed 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.

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  • Withdrawn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

Generic Name
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Model / Reference
DR0850B
Primary DI / UDI-DI
05032384029051
Basic UDI-DI
5032384StaphytectPlusNH
FDA Product Code
JWX
EMDN Code
W0104080303 Staphylococci slide tests
GMDN Term
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
866.2660
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class I

Manufacturer details

EUDAMED SRN
GB-MF-000016914
Authorised representative
Thermo Fisher Diagnostics B.V. NL-AR-000013157

Other devices from Oxoid Ltd

See all devices from Oxoid Ltd →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

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