FDA.reportPublic FDA data

Oragene Dx

Primary DI
00627595000262
Brand
Oragene Dx
Company
DNA Genotek Inc
Model
OGD-675
Device description
DNA Specimen Collection, Saliva (For Assisted Collection)
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K152556000
K192920000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152556000Oragene DxDNA Genotek, Inc.2016-05-26OYJ
K192920000Oragene®•DxDNA Genotek, Inc.2020-01-14OYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627595000262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627595000262006275950002626275950002620627595000262

GMDN Terms#

Term, Definition table
TermDefinition
Specimen mailer kitA collection of non-sterile items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form, and a specimen container mailer. It is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

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
00627595000279Oragene DxOXD-5002025-09-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00627595000279Oragene DxDNA Genotek IncOYJ2025-09-08
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
00627595000019Oragene DxDNA Genotek IncOYJ2016-09-08
00627595000026Oragene DxDNA Genotek IncOYJ2016-09-08
00627595000132Oragene DxDNA Genotek IncOYJ2016-09-08
00627595000224Oragene DxDNA Genotek IncOYJ2016-09-08