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Gram-Polychrome JetDye-AF System Kit

by Bio-Gram Diagnostics GmbH Germany EUDAMEDGUDID

Ref SK2209201 Product code JTSEMDN W0104010804

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04262400022013 UDI-DIDate19 Jun 2026ListedStatusIn distribution
European UnionCE/IVDR EUDAMED Number426240002GPJetDye3Y Basic UDI-DIDate2 Mar 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 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
Gram-Polychrome JetDye-AF System Kit EUDAMED
Gram-Polychrom JetDye-AF System Kit GUDID
Generic Name
Gram stain IVD, reagent
Device Name
Gram-Polychrome JetDye-AF Kit
Model / Ref / Catalog
SK2209201, 1
Primary DI / UDI-DI
04262400022013 EUDAMED
14262400022010 GUDID
Basic UDI-DI
426240002GPJetDye3Y
Direct Marketing DI
04262400022013
FDA Product Code
JTS
EMDN Code
W0104010804 Stains
GMDN Term
Gram stain IVD, reagent
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 · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SK2209201
GUDID
1
Primary DI / UDI-DIEUDAMED
04262400022013
GUDID
14262400022010
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000032559

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See all devices from Bio-Gram Diagnostics GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • Convenience Kit
  • 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 (2)

  • EUDAMED d989053b-77ad-4117-ad9f-8be8e4d81ad8 61 fields · synced 23 Oct 2026
  • FDA UDI 55c52ce9-c430-45ee-bba0-7e4db43eae65 36 fields · synced 23 Oct 2026