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JB-2 Staining System

by Wallac Oy

Ref FR-9367

JB-2 Staining System (FR-9367) is a device classified as Class A in the EU and Class II in the US made by Wallac Oy, registered in EUDAMED on 30 Jun 2022 (Basic UDI-DI 6438147RESOLVE_JB2G7), cleared under FDA 510(k) K050709 on 8 Mar 2006 and listed in FDA GUDID since 2 Feb 2016 (UDI-DI 06438147000807), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K050709

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number6438147RESOLVE_JB2G7 Basic UDI-DI 06438147000807UDI-DIDate30 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06438147000807 UDI-DI Date2 Feb 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK050709 Date8 Mar 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6438147RESOLVE_JB2G7 registered 30 Jun 2022 Active
  • FDA 510(k) K050709 decided 8 Mar 2006 Active
  • FDA GUDID UDI-DI 06438147000807 listed 2 Feb 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2685-2017 FDA Class II initiated 15 May 2017 on shared 510(k) K050709

    Potential for electric shock in the case of a failure to install the grommets, supplied with the system.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K050709
  2. Listed FDA GUDID 06438147000807
  3. Recall initiated FDA recalls Z-2685-2017
  4. Registered EUDAMED 6438147RESOLVE_JB2G7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
JB-2 Staining System EUDAMED
RESOLVE Systems JB-2 Staining System GUDID
Generic name
Multiple haemoglobin subtype IVD, kit, electrophoresis
Model / Ref / Catalog
FR-9367
Primary DI / UDI-DI
06438147000807
Basic UDI-DI
6438147RESOLVE_JB2G7
510(k) Number
FDA product code
GKA
EMDN code
W01030199 Haematology reagents - other
GMDN term
Multiple haemoglobin subtype IVD, kit, electrophoresis
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.7415
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FI-MF-000022620

Similar devices in this category

Other devices filed under HAEMATOLOGY REAGENTS - OTHER.

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Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)