FDA.reportPublic FDA data

OMNIgene GUT Dx

Primary DI
00627595000507
Brand
OMNIgene GUT Dx
Company
DNA Genotek Inc
Model
OMD-200
Device description
Microbial DNA Collection and Stabilization, Human Fecal Samples
Published
2022-11-18
Public version status
Update
Distribution status
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
QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical SamplesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200040000OMNIgene GUT DxDNA Genotek, Inc.2021-11-03QPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627595000774PackageGS11Not in Commercial Distribution
10627595000504PackageGS125In Commercial Distribution
10627595001426PackageGS11In Commercial Distribution
10627595001433PackageGS11In Commercial Distribution
10627595001464PackageGS11In Commercial Distribution
10627595001471PackageGS11In Commercial Distribution
00627595000507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627595000774006275950007746275950007740627595000774
1062759500050410627595000504
1062759500142610627595001426
1062759500143310627595001433
1062759500146410627595001464
1062759500147110627595001471
00627595000507006275950005076275950005070627595000507

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen container IVD, DNA preservation solutionA covered plastic receptacle containing a deoxyribonucleic acid (DNA) preservation solution intended to be used for the collection, preservation, and transport of DNA present in a faecal specimen for analysis and/or other investigation [e.g., evaluation for the presence of genetic markers for certain gastrointestinal cancers (e.g., colorectal, pancreatic)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 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
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
00627595000774OMNIgene GUT DxDNA Genotek IncQPO2022-11-18