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Wright-Giemsa JetDye-AF System Kit

by Bio-Gram Diagnostics GmbH Germany EUDAMEDGUDID

Ref SK2209203, RG2209022 Product code GJLEMDN W0103010302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04262400022037 UDI-DIDate19 Jun 2026ListedStatusIn distribution
European UnionCE/IVDR EUDAMED Number426240002JetDyeKE Basic UDI-DIDate22 Jan 2026RegisteredStatusActive

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 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Wright-Giemsa JetDye-AF System Kit
Wright-Giemsa JetDye-AF
Generic Name
Differentiation solution IVD
Device Name
MGG JetDye-AF Kit
Model / Ref / Catalog
SK2209203, RG2209022, 1
Primary DI / UDI-DI
04262400022037, 04262400020224, 14262400022034
Basic UDI-DI
426240002JetDyeKE
Direct Marketing DI
04262400022037
04262400020224
FDA Product Code
GJL
EMDN Code
W0103010302 Romanowsky stains
GMDN Term
Differentiation solution IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.1850
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SK2209203
RG2209022
GUDID
1
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000032559

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • Convenience Kit NoGUDIDYesGUDID
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (4)

  • EUDAMED bb726e6f-3ee9-4da2-b98f-6f4d1c02b5ab 61 fields · synced 22 Oct 2026
  • EUDAMED 04262400020224|426240002JETDYEKE 61 fields · synced 18 May 2026
  • FDA UDI 736095f2-2c6c-45a6-90c2-e9f7e940180e 35 fields · synced 23 Oct 2026
  • FDA UDI baef4ca3-152d-46dc-bfd3-7cb359feed97 36 fields · synced 23 Oct 2026