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ORAgene Dx

by DNA Genotek Inc. 7 variants

Ref OGD-675

ORAgene Dx (OGD-675) is a device classified as Class A in the EU and Class II in the US made by DNA Genotek Inc, registered in EUDAMED on 11 Jun 2024 (Basic UDI-DI 0627595A0100EF), cleared under FDA 510(k) K192920 on 14 Jan 2020 (1 earlier submission) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00627595000262), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K192920

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0627595A0100EF Basic UDI-DI 00627595000262UDI-DIDate11 Jun 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192920 Date14 Jan 2020DecidedStatusActive
United StatesGUDID listing GUDID Number00627595000262 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0627595A0100EF registered 11 Jun 2024 Active
  • FDA 510(k) K192920 decided 14 Jan 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00627595000262 listed 9 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

4 dated events

  1. Cleared FDA 510(k) K152556
  2. Listed FDA GUDID 00627595000262
  3. Cleared FDA 510(k) K192920
  4. Registered EUDAMED 0627595A0100EF

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Specimen stabilization reagent IVD
Device name
ORAgene (Swab-based DNA & Dx Collection Device)
Model / reference
OGD-675
Primary DI / UDI-DI
00627595000262
Basic UDI-DI
0627595A0100EF
510(k) Number
FDA product code
OYJ
EMDN code
A1101, W05019002
GMDN term
Specimen stabilization reagent IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.1675
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CA-MF-000003486
Authorised representative
QbD RepS BV BE-AR-000000040

Similar devices in this category

Other devices filed under SALIVA COLLECTION DEVICES.

Other devices from DNA Genotek Inc

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Properties

  • Single use
  • IVD kit
  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)