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One Step Multi-Drug Screen Test Cup (Urine)

by Healgen Scientific Limited Liability Company 4 variants

Ref GBDOA-1X6-ALC

Active European Union and United States

CE IVDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163704↗

+3 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-GBDOA-1X6-ALCHGJP Basic UDI-DI D-GBDOA-1X6-ALCHGJPUDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK163704 Date2 Aug 2017IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
GBDOA-1X6-ALC
Primary DI / UDI-DI
D-GBDOA-1X6-ALCHGJP
Basic UDI-DI
B-GBDOA-1X6-ALCHGJP
EMDN Code
W0102160511 Multiple drugs of abuse/toxicology rt & poc
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The One Step Multi-Drug Screen Test Cup (Urine) is an IVD General device, classified as a kit, used for professional testing. It is designed to screen for multiple drugs in urine samples.

The device is supplied non-sterile, with a reference code of GBDOA-1X6-ALC, and is authorized under FDA_510K and IVDD. It is available with a unique device identifier (UDI) and is intended for use in settings such as workplaces and clinics.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the One Step Multi-Drug Screen Test Cup used for?

    The One Step Multi-Drug Screen Test Cup is used for professional testing to screen for multiple drugs in urine samples, typically in settings such as workplaces and clinics.

  • Is the One Step Multi-Drug Screen Test Cup supplied sterile?

    No, the One Step Multi-Drug Screen Test Cup is supplied non-sterile, as indicated by the STERILE field being set to 0.

  • What is the reference code for the One Step Multi-Drug Screen Test Cup?

    The reference code for the One Step Multi-Drug Screen Test Cup is GBDOA-1X6-ALC, which is also the device model.

  • Is the One Step Multi-Drug Screen Test Cup intended for professional or self-testing?

    The One Step Multi-Drug Screen Test Cup is intended for professional testing, as indicated by the PROFESSIONAL_TESTING field being set to 1.

Properties

  • Animal Tissues
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No