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BOND-PRIME Polymer AP Detection System

by Leica Biosystems Newcastle Ltd

Ref DS9304

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number50553313PRIPAP0000583 Basic UDI-DI 05055331330574UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055331330574 UDI-DI Date7 Dec 2022ListedStatusListed 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  • Withdrawn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

Trade Name
BOND-PRIME Polymer AP Detection System EUDAMED
Bond-Prime GUDID
Generic Name
Immunohistochemistry antibody detection IVD, reagent
Model / Ref / Catalog
DS9304
Primary DI / UDI-DI
05055331330574
Basic UDI-DI
50553313PRIPAP0000583
Direct Marketing DI
05055331330574
FDA Product Code
NJT
EMDN Code
W01030711 Immunohistology kits
GMDN Term
Immunohistochemistry antibody detection IVD, reagent
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
GB-MF-000020595
Authorised representative
AR Experts B.V. NL-AR-000023989

Related devices

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Other devices from Leica Biosystems Newcastle, Limited

See all devices from Leica Biosystems Newcastle, Limited →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No