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ARK Ketamine II Assay

by ARK Diagnostics, Inc. 4 variants

Ref 5083-0001-03Model 5083-0001-00

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0858724003KET0833G Basic UDI-DI 00812101031995UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812101031995 UDI-DI Date27 Dec 2025ListedStatusListed 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  • Withdrawn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

Generic Name
Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
5083-0001-00, 5083-0001-03
Primary DI / UDI-DI
00812101031995
Basic UDI-DI
0858724003KET0833G
Direct Marketing DI
00812101031995
FDA Product Code
LCM
EMDN Code
W0102090199 Drugs of abuse - other
GMDN Term
Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
U GUDID
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
U

Manufacturer details

EUDAMED SRN
US-MF-000023925
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Ark Diagnostics Inc

See all devices from Ark Diagnostics Inc →

Properties

  • Single Use
  • Animal Tissues
  • Reagent
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No