Home GUDID 00627595000774 OMNIgene GUT Dx
Primary DI 00627595000774
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 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 QPO Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QPO Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00627595000774 Package GS1 1 In Commercial Distribution 10627595000504 Package GS1 25 In Commercial Distribution 10627595001426 Package GS1 1 In Commercial Distribution 10627595001433 Package GS1 1 In Commercial Distribution 10627595001464 Package GS1 1 In Commercial Distribution 10627595001471 Package GS1 1 In Commercial Distribution 00627595000507 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 00627595000774 00627595000774 627595000774 0627595000774 10627595000504 10627595000504 10627595001426 10627595001426 10627595001433 10627595001433 10627595001464 10627595001464 10627595001471 10627595001471 00627595000507 00627595000507 627595000507 0627595000507
GMDN Terms# Term, Definition table Term Definition Faecal specimen container IVD, DNA preservation solution A 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 Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 59 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 207983508 Device count 1 DM exempt false Premarket exempt false 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 00627595000507 OMNIgene GUT Dx DNA Genotek Inc QPO 2022-11-18
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