FDA.reportPublic FDA data

Oragene Dx

Primary DI
00627595000279
Brand
Oragene Dx
Company
DNA Genotek Inc
Model
OXD-500
Device description
DNA Specimen collection, Saliva
Published
2025-09-08
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYJDna Specimen Collection, Saliva

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYJDna Specimen Collection, SalivaClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110701000ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500DNA Genotek, Inc.2011-12-02OYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627595000279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627595000279006275950002796275950002790627595000279

GMDN Terms#

Term, Definition table
TermDefinition
Specimen stabilization reagent IVDA substance or reactant intended to be used alone or in combination with other IVDs to prevent degradation of sensitive analytes (e.g., hormones, proteins, peptides and/or nucleic acids) in a clinical specimen during transportation, storage or processing. A stabilizer is typically a solvent, antioxidant or an enzyme inhibitor.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-813-6354info@dnagenotek.com

Regulatory Flags#

DUNS number
207983508
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627595000286Oragene DxOYD-5002025-09-08
00627595001627Colli-PeeColli-Pee FV-5020N000552024-12-09
00627595001634Colli-PeeColli-Pee FV-5010N003092024-12-09
00627595001641Colli-PeeColli-Pee FV-5020cN002382024-12-09
00627595001658Colli-PeeColli-Pee FV-5004N002902024-12-09
00627595001665Colli-PeeColli-Pee FV-5040N002692024-12-09
00627595001672Colli-PeeColli-Pee UCM FV-5020N001762024-12-09
00627595001689Colli-PeeColli-Pee UCM FV-5010N003272024-12-09
00627595001696Colli-PeeColli-Pee UCM FV-5003bN003832024-12-09
00627595001702Colli-PeeColli-Pee UCM FV-5004N002602024-12-09
00627595001719Colli-PeeColli-Pee UAS FV-5040N003422024-12-09
00627595000507OMNIgene GUT DxOMD-2002022-11-18
00627595000712ORAcollect DxOCD-100.0142022-11-18
00627595000132Oragene DxOGD-5102016-09-08
00627595000248Oragene DxOGD-6002016-09-09
00627595000255Oragene DxOGD-6102016-09-09
00627595000309ORAcollect DxOCD-1002016-09-10
00627595000682Accessory SpongesOG-AC12022-11-21
00627595000316ORAcollect DxOCD-100A2022-11-18
00627595000675OMNIgene ORALOME-5052022-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00627595000286Oragene DxDNA Genotek IncOYJ2025-09-08
00860014139307Color Saliva Collection KitColor Diagnostics, LLCOYJ2025-06-09
00627595000316ORAcollect DxDNA Genotek IncOYJ2022-11-18
00627595000712ORAcollect DxDNA Genotek IncOYJ2022-11-18
10627595000313ORAcollect DxDNA Genotek IncOYJ2022-11-18
10627595000825ORAcollect DxDNA Genotek IncOYJ2022-11-18
00850032976114Truepill Inc.Postmeds, Inc.OYJ2022-05-19
00627595000309ORAcollect DxDNA Genotek IncOYJ2016-09-10
00627595000248Oragene DxDNA Genotek IncOYJ2016-09-09
00627595000255Oragene DxDNA Genotek IncOYJ2016-09-09
00627595000262Oragene DxDNA Genotek IncOYJ2016-09-09
00627595000019Oragene DxDNA Genotek IncOYJ2016-09-08
00627595000026Oragene DxDNA Genotek IncOYJ2016-09-08
00627595000132Oragene DxDNA Genotek IncOYJ2016-09-08
00627595000224Oragene DxDNA Genotek IncOYJ2016-09-08