FDA.reportPublic FDA data

ORAcollect Dx

Primary DI
00627595000316
Brand
ORAcollect Dx
Company
DNA Genotek Inc
Model
OCD-100A
Device description
DNA Specimen Collection, Saliva
Published
2022-11-18
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627595001009PackageGS11In Commercial Distribution
00627595001023PackageGS11In Commercial Distribution
00627595001047PackageGS11In Commercial Distribution
00627595001061PackageGS11In Commercial Distribution
10627595000313PackageGS125In Commercial Distribution
10627595001013PackageGS125In Commercial Distribution
10627595001037PackageGS125In Commercial Distribution
10627595001051PackageGS125In Commercial Distribution
10627595001075PackageGS125In Commercial Distribution
00627595000316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627595001009006275950010096275950010090627595001009
00627595001023006275950010236275950010230627595001023
00627595001047006275950010476275950010470627595001047
00627595001061006275950010616275950010610627595001061
1062759500031310627595000313
1062759500101310627595001013
1062759500103710627595001037
1062759500105110627595001051
1062759500107510627595001075
00627595000316006275950003166275950003160627595000316

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection swabA piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit78 Degrees Fahrenheit

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
00627595000675OMNIgene ORALOME-5052022-11-18

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
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