Dna Genotek Inc

FDA Filings

This page includes the latest FDA filings for Dna Genotek Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003742580
FEI Number3003742580
NameTiffany A Miller
Owner & OperatorDNA GENOTEK, INC.
Contact Address3000 - 500 Palladium Drive
Ottawa CA-ON Ontario K2V 1C2 CA
Official Correspondent
  • Austin Udocor
  • 01-613-7235757-245
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOraSure Technologies, Inc. 220 East First Street
Bethlehem, PA 18015 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
DNA Genotek Inc
Accessory Sponges 2022-11-29
DNA Genotek Inc
OMNIgene ORAL 2022-11-28
DNA Genotek Inc
ORAcollect Dx 2022-11-28
DNA Genotek Inc
ORAcollect Dx 2022-11-28
DNA Genotek Inc
OMNIgene GUT Dx 2022-11-28
DNA Genotek Inc
OMNIgene Liquefaction Reagent 2022-11-28
DNA Genotek Inc
OMNIgene Liquefaction Reagent 2022-11-28
DNA Genotek Inc
PrepIT L2P PT-L2P-452022-11-28
DNA Genotek Inc
PrepIT L2P PT-L2P-52022-11-28
DNA Genotek Inc
ORAcollect®•Dx2022-10-27
DNA Genotek Inc.
Oragene®•Dx2020-01-14
DNA Genotek Inc
ORAcollect Dx 2018-07-06
DNA Genotek Inc
Oragene Dx 2018-07-06
DNA Genotek Inc
Oragene Dx 2018-07-06
DNA Genotek Inc
Oragene Dx 2018-07-06
DNA Genotek Inc
Oragene Dx 2018-07-06
DNA Genotek Inc
Oragene Dx 2018-07-06
DNA Genotek Inc
Oragene Dx 2018-07-06
DNA Genotek Inc
Oragene Dx 2018-07-06
Tiffany A Miller [DNA GENOTEK, INC.]
Oragene Dx (OGD-510, OGD-600, OGD-610, OGD-675)2016-06-20
Tiffany A Miller [DNA GENOTEK, INC.]
ORAcollect Dx (OCD-100, OCD-100A)2016-06-03
DNA Genotek Inc
Oragene Dx2016-05-26
DNA GENOTEK INC.
ORAcollect.Dx2016-05-26
Tiffany A Miller [DNA GENOTEK, INC.]
Oragene Dx (OGD-500.001)2015-03-03
DNA GENOTEK, INC.
ORAGENE DX OGD-500.0012015-02-19
Tiffany A Miller [DNA GENOTEK, INC.]
HEMAgene BUFFY COAT (HG-BCD-50, HG-BCD-250)2015-01-23
Tiffany A Miller [DNA GENOTEK, INC.]
Oragene RNA (RE-100)2012-01-27
Tiffany A Miller [DNA GENOTEK, INC.]
Oragene DISCOVER (OGR-250, OGR-500, OGR-575)2012-01-27
Tiffany A Miller [DNA GENOTEK, INC.]
ORAcollect for Pediatrics (OC-175)2012-01-27
Tiffany A Miller [DNA GENOTEK, INC.]
OMNIgene VAGINAL (OMR-130)2012-01-27
Tiffany A Miller [DNA GENOTEK, INC.]
OMNIgene ORAL (OM-501, OM-505, OMR-110, OMR-120)2012-01-27
Tiffany A Miller [DNA GENOTEK, INC.]
OMNIgene GUT (OMR-200)2012-01-27
Tiffany A Miller [DNA GENOTEK, INC.]
Oragene Dx (OGD-500, OGD-575)2012-01-16
DNA GENOTEK INC
ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-5002011-12-02
Tiffany A Miller [DNA GENOTEK, INC.]
PrepIT Q2A (PT-Q2A-96, PT-Q2A-384)2011-03-16
Tiffany A Miller [DNA GENOTEK, INC.]
PrepIT L2P (PT-L2P-1.5, PT-L2P-5, PT-L2P-45)2011-03-16
Tiffany A Miller [DNA GENOTEK, INC.]
OMNIgene SPUTUM (OM-SPD-50, OM-SPD-250, OM-SPD-1000)2011-03-16
Tiffany A Miller [DNA GENOTEK, INC.]
OMNIgene Liquefaction Reagent (OM-LQR-400, OM-LQR-1600)2011-03-16
Tiffany A Miller [DNA GENOTEK, INC.]
Accessories, sample collection: CS-1, CS-2, OG-AC12011-03-16

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