Home GUDID 10627595001136 OMNIgene ORAL
Primary DI 10627595001136
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
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name LIO Device, Specimen Collection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIO Device, Specimen Collection Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00627595000798 Package GS1 1 In Commercial Distribution 10627595000795 Package GS1 1 In Commercial Distribution 10627595001136 Package GS1 1 In Commercial Distribution 00627595000675 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00627595000798 00627595000798 627595000798 0627595000798 10627595000795 10627595000795 10627595001136 10627595001136 00627595000675 00627595000675 627595000675 0627595000675
GMDN Terms# Term, Definition table Term Definition Oral/respiratory tract specimen container IVD, additive/medium A 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 Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 207983508 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884999051690 simpli-COLLECT ABBOTT MOLECULAR INC. LIO 2026-04-13 38053326011826 BD FCT COPAN ITALIA SPA LIO 2026-01-26 05060441760036 binx io BINX HEALTH LIMITED LIO 2025-09-03 05060441760043 binx io BINX HEALTH LIMITED LIO 2025-09-03 15060441760033 binx io BINX HEALTH LIMITED LIO 2025-09-03 15060441760040 binx io BINX HEALTH LIMITED LIO 2025-09-03 00848838066665 Amies Clear Gel,Single Swab PK/500 REMEL, INC. LIO 2025-06-18 00848838066672 Amies Clear Gel,Single Swab PK/50 REMEL, INC. LIO 2025-06-18 00848838066689 Amies Clear Gel,Dual Swab PK/500 REMEL, INC. LIO 2025-06-18 00848838066696 Amies Clear Gel,Dual Swab PK/50 REMEL, INC. LIO 2025-06-18 00848838066702 Amies Clear Gel,Wire Shaft Swab PK/100 REMEL, INC. LIO 2025-06-18 00848838066719 Amies Clear Gel,Wire Shaft PK/50 REMEL, INC. LIO 2025-06-18 00848838066757 Amies Charcoal Gel,Single Swab PK/50 REMEL, INC. LIO 2025-06-18 38053326009557 Copan Universal Transport Medium (UTM-RT) System COPAN ITALIA SPA LIO 2025-05-28 38053326009861 Copan Universal Transport Medium (UTM-RT) System COPAN ITALIA SPA LIO 2025-05-28 38053326010287 Copan Universal Transport Medium (UTM-RT) System COPAN ITALIA SPA LIO 2025-05-28 38053326010447 Copan Universal Transport Medium (UTM-RT) System COPAN ITALIA SPA LIO 2025-05-28 38053326011079 Copan Universal Transport Medium (UTM-RT) System COPAN ITALIA SPA LIO 2025-05-28 38053326011185 Copan Universal Transport Medium (UTM-RT) System COPAN ITALIA SPA LIO 2025-05-28 58053326010403 Copan Universal Transport Medium (UTM-RT) System COPAN ITALIA SPA LIO 2025-05-28 38053326011710 UriSponge™ COPAN ITALIA SPA LIO 2025-03-12 00840165400303 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-21 00840165400327 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-21 00840165400341 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-21 00840165400310 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-21 00840165400334 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-21 00840165400358 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-21 00840165400075 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-19 00840165400105 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-19 00840165400129 Starswab II Bacteriology Culture Collection and Transport System Pretium Canada Packaging ULC LIO 2025-02-19
dnagenotek.com