Oragene Dx

GUDID 00627595000026

DNA Specimen Collection, Saliva (For Over-the-Counter Use)

DNA Genotek Inc

Specimen mailer kit
Primary Device ID00627595000026
NIH Device Record Key25eacbdd-572b-4522-88b3-69d7ff5f0af8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOragene Dx
Version Model NumberOGD-500.001
Company DUNS207983508
Company NameDNA Genotek Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1 866 813 6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100627595000026 [Primary]
GS110627595000740 [Package]
Package: OGD-500.001+ACP244 [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OYJDna Specimen Collection, Saliva

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-08

On-Brand Devices [Oragene Dx]

00627595000262DNA Specimen Collection, Saliva (For Assisted Collection)
00627595000255DNA Specimen Collection, Saliva
00627595000248DNA Specimen Collection, Saliva
00627595000224DNA Specimen Collection, Saliva (For assisted collection)
00627595000132DNA Specimen Collection, Saliva
00627595000026DNA Specimen Collection, Saliva (For Over-the-Counter Use)
00627595000019DNA Specimen Collection, Saliva
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