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ORAgene Dx

by DNA Genotek Inc. 7 variants

Part of a family of 8 devices: see the family page

Ref OGD-600

ORAgene Dx (OGD-600) 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 12 Jun 2024 (Basic UDI-DI 0627595E0500GF), cleared under FDA 510(k) K192920 on 14 Jan 2020 (1 earlier submission) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00627595000248), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192920

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0627595E0500GF Basic UDI-DI 00627595000248UDI-DIDate12 Jun 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192920 Date14 Jan 2020DecidedStatusActive
United StatesGUDID listing GUDID Number00627595000248 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK152556 Date26 May 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0627595E0500GF registered 12 Jun 2024 Active
  • FDA 510(k) K192920 decided 14 Jan 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00627595000248 listed 9 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K152556
  2. Listed FDA GUDID 00627595000248
  3. Cleared FDA 510(k) K192920
  4. Registered EUDAMED 0627595E0500GF

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Specimen stabilization reagent IVD
Device name
ORAgene
Model / reference
OGD-600
Primary DI / UDI-DI
00627595000248
Basic UDI-DI
0627595E0500GF
510(k) Number
FDA product code
OYJ
EMDN code
W05019002 Saliva collection devices
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

See all devices from DNA Genotek Inc →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)