Skip to content

ARK AB-PINACA Assay

by ARK Diagnostics, Inc. 2 variants

Ref 5055-0001-01Model 5055-0001-00

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 Number0858724003ABP055V9 Basic UDI-DI 00812101030356UDI-DIDate31 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812101030356 UDI-DI Date23 Jul 2019ListedStatusListed 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  • Withdrawn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
Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
5055-0001-00, 5055-0001-01
Primary DI / UDI-DI
00812101030356
Basic UDI-DI
0858724003ABP055V9
Direct Marketing DI
00812101030356
FDA Product Code
LDJ
EMDN Code
W0102090105 Cannabinoids
GMDN Term
Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.3870
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
Class II

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
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient 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