Home GUDID 00627595000132 Oragene Dx
Primary DI 00627595000132
Brand Oragene Dx
Company DNA Genotek Inc
Model OGD-510
Device description DNA Specimen Collection, Saliva
Published 2016-09-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Single use true Product Codes# Code, Name table Code Name OYJ Dna Specimen Collection, Saliva
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OYJ Dna Specimen Collection, Saliva Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00627595000125 Package GS1 1 In Commercial Distribution 00627595000156 Package GS1 1 In Commercial Distribution 00627595000194 Package GS1 1 In Commercial Distribution 00627595000200 Package GS1 1 In Commercial Distribution 00627595000231 Package GS1 1 In Commercial Distribution 00627595000491 Package GS1 1 In Commercial Distribution 00627595000705 Package GS1 1 In Commercial Distribution 00627595001269 Package GS1 1 In Commercial Distribution 00627595001566 Package GS1 1 In Commercial Distribution 10627595000870 Package GS1 1 In Commercial Distribution 10627595000887 Package GS1 1 In Commercial Distribution 10627595000917 Package GS1 1 In Commercial Distribution 10627595000924 Package GS1 2 In Commercial Distribution 10627595000931 Package GS1 3 In Commercial Distribution 10627595000948 Package GS1 4 In Commercial Distribution 10627595000986 Package GS1 1 In Commercial Distribution 10627595001273 Package GS1 1 In Commercial Distribution 10627595001280 Package GS1 1 In Commercial Distribution 10627595001297 Package GS1 1 In Commercial Distribution 10627595001358 Package GS1 1 In Commercial Distribution 10627595001501 Package GS1 1 In Commercial Distribution 10627595001518 Package GS1 1 In Commercial Distribution 10627595001570 Package GS1 1 In Commercial Distribution 10627595001587 Package GS1 1 In Commercial Distribution 00627595000132 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 00627595000125 00627595000125 627595000125 0627595000125 00627595000156 00627595000156 627595000156 0627595000156 00627595000194 00627595000194 627595000194 0627595000194 00627595000200 00627595000200 627595000200 0627595000200 00627595000231 00627595000231 627595000231 0627595000231 00627595000491 00627595000491 627595000491 0627595000491 00627595000705 00627595000705 627595000705 0627595000705 00627595001269 00627595001269 627595001269 0627595001269 00627595001566 00627595001566 627595001566 0627595001566 10627595000870 10627595000870 10627595000887 10627595000887 10627595000917 10627595000917 10627595000924 10627595000924 10627595000931 10627595000931 10627595000948 10627595000948 10627595000986 10627595000986 10627595001273 10627595001273 10627595001280 10627595001280 10627595001297 10627595001297 10627595001358 10627595001358 10627595001501 10627595001501 10627595001518 10627595001518 10627595001570 10627595001570 10627595001587 10627595001587 00627595000132 00627595000132 627595000132 0627595000132
GMDN Terms# Term, Definition table Term Definition Specimen mailer kit A collection of non-sterile items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form, and a specimen container mailer. It is normally available [non-prescription] over-the-counter (OTC). 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 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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