FDA.reportPublic FDA data

DNA GENOTEK, INC.

Matched from indexed company URL: DNA Genotek Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037425803003742580DNA GENOTEK, INC.1N2026-01-013000 - 500 Palladium Drive Ottawa Ontario CA K2V 1C2

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00627595000279Oragene Dx - DNA Specimen collection, Saliva1-866-813-6354info@dnagenotek.com
00627595000286Oragene Dx - DNA Specimen Collection, Saliva1-866-813-6354info@dnagenotek.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
214671569776682K212745ORAcollect®•DxOYJ2022-10-27
214671291612024K192920Oragene®•DxOYJ2020-01-14
214672003731289K152556Oragene DxOYJ2016-05-26
214671887623686K152464ORAcollect.DxOYJ2016-05-26
214671804938633K141410ORAGENE DX OGD-500.001OYJ2015-02-19
214671591768047K110701ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500OYJ2011-12-02
214671054383013DEN200040OMNIgene GUT DxQPO2021-11-03
214671136443251
214671221793706
214671383257369
214671405756534
214671587781537
214671651160955
214671895475452
214671908249790
214672007683396

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OYJ62022-10-27
QPO12021-11-03

PMN#

GUDID#