Home GUDID 00627595000309 ORAcollect Dx
Primary DI 00627595000309
Brand ORAcollect Dx
Company DNA Genotek Inc
Model OCD-100
Device description DNA Specimen Collection, Saliva
Published 2016-09-10
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 00627595000040 Package GS1 1 In Commercial Distribution 00627595000057 Package GS1 1 In Commercial Distribution 00627595000163 Package GS1 25 In Commercial Distribution 00627595000170 Package GS1 25 In Commercial Distribution 00627595000835 Package GS1 1 In Commercial Distribution 00627595001085 Package GS1 1 In Commercial Distribution 00627595001108 Package GS1 1 In Commercial Distribution 00627595001146 Package GS1 1 In Commercial Distribution 10627595000047 Package GS1 25 In Commercial Distribution 10627595000078 Package GS1 10 In Commercial Distribution 10627595000306 Package GS1 25 In Commercial Distribution 10627595000832 Package GS1 10 In Commercial Distribution 10627595000856 Package GS1 1 In Commercial Distribution 10627595000863 Package GS1 1 In Commercial Distribution 10627595000955 Package GS1 25 In Commercial Distribution 10627595000993 Package GS1 1 In Commercial Distribution 10627595001099 Package GS1 1 In Commercial Distribution 10627595001112 Package GS1 25 In Commercial Distribution 10627595001150 Package GS1 25 In Commercial Distribution 10627595001327 Package GS1 25 In Commercial Distribution 10627595001365 Package GS1 1 In Commercial Distribution 10627595001372 Package GS1 1 In Commercial Distribution 00627595000309 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 00627595000040 00627595000040 627595000040 0627595000040 00627595000057 00627595000057 627595000057 0627595000057 00627595000163 00627595000163 627595000163 0627595000163 00627595000170 00627595000170 627595000170 0627595000170 00627595000835 00627595000835 627595000835 0627595000835 00627595001085 00627595001085 627595001085 0627595001085 00627595001108 00627595001108 627595001108 0627595001108 00627595001146 00627595001146 627595001146 0627595001146 10627595000047 10627595000047 10627595000078 10627595000078 10627595000306 10627595000306 10627595000832 10627595000832 10627595000856 10627595000856 10627595000863 10627595000863 10627595000955 10627595000955 10627595000993 10627595000993 10627595001099 10627595001099 10627595001112 10627595001112 10627595001150 10627595001150 10627595001327 10627595001327 10627595001365 10627595001365 10627595001372 10627595001372 00627595000309 00627595000309 627595000309 0627595000309
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 25 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 59 Degrees Fahrenheit 77 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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