FDA.reportPublic FDA data

OMNIgene ORAL

Primary DI
00627595000675
Brand
OMNIgene ORAL
Company
DNA Genotek Inc
Model
OME-505
Device description
Nucleic Acids Specimen Collection and Stabilization, 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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIODevice, Specimen Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627595000798PackageGS11In Commercial Distribution
10627595000795PackageGS11In Commercial Distribution
10627595001136PackageGS11In Commercial Distribution
00627595000675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627595000798006275950007986275950007980627595000798
1062759500079510627595000795
1062759500113610627595001136
00627595000675006275950006756275950006750627595000675

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. 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

Contacts#

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

Regulatory Flags#

DUNS number
207983508
Device count
1
Premarket exempt
true
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
00884999051690simpli-COLLECTABBOTT MOLECULAR INC.LIO2026-04-13
38053326011826BD FCTCOPAN ITALIA SPALIO2026-01-26
05060441760036binx ioBINX HEALTH LIMITEDLIO2025-09-03
05060441760043binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760033binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760040binx ioBINX HEALTH LIMITEDLIO2025-09-03
00848838066665Amies Clear Gel,Single Swab PK/500REMEL, INC.LIO2025-06-18
00848838066672Amies Clear Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
00848838066689Amies Clear Gel,Dual Swab PK/500REMEL, INC.LIO2025-06-18
00848838066696Amies Clear Gel,Dual Swab PK/50REMEL, INC.LIO2025-06-18
00848838066702Amies Clear Gel,Wire Shaft Swab PK/100REMEL, INC.LIO2025-06-18
00848838066719Amies Clear Gel,Wire Shaft PK/50REMEL, INC.LIO2025-06-18
00848838066757Amies Charcoal Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011710UriSponge™COPAN ITALIA SPALIO2025-03-12
00840165400303Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400327Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400341Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400310Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400334Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400358Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400075Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400105Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400129Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19