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Bond™ PA0843

by Leica Biosystems Newcastle, Limited

Ref PA0843

Bond™ PA0843 is a device classified as IVD General (EU), Class I (US) made by Leica Biosystems Newcastle, Limited, registered in EUDAMED on 5 Jun 2026 (Basic UDI-DI B-05055331303806) and listed in FDA GUDID since 9 Apr 2021 (UDI-DI 05055331303806), active as of 22 Oct 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05055331303806 Basic UDI-DI 05055331303806UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055331303806 UDI-DI Date9 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055331303806 registered 5 Jun 2026 Active
  • FDA GUDID UDI-DI 05055331303806 listed 9 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055331303806
  2. Registered EUDAMED B-05055331303806

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  • Withdrawn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
CD19 BT51E 7 mL EUDAMED
Bond™ GUDID
Generic name
CD19 cell marker IVD, antibody
Device name
BOND Ready-to-Use Primary Antibody CD19 (BT51E)
Model / Ref / Catalog
PA0843
Primary DI / UDI-DI
05055331303806
Basic UDI-DI
B-05055331303806
FDA product code
NJT
EMDN code
W01030709 Primary antisera for immunohistology
GMDN term
CD19 cell marker IVD, antibody
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
864.1860
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: CD19 cell marker IVD, antibody

Similar devices in this category

Other devices filed under PRIMARY ANTISERA FOR IMMUNOHISTOLOGY.

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Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)