Oragene Dx

GUDID 00627595000132

DNA Specimen Collection, Saliva

DNA Genotek Inc

Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen mailer kit Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD Specimen stabilization reagent IVD
Primary Device ID00627595000132
NIH Device Record Keyf4c8cae3-7eba-4a68-946e-2b33d952366e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOragene Dx
Version Model NumberOGD-510
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 Perscriptiontrue
OTC Over-The-Counterfalse

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
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 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
GS100627595000125 [Package]
Package: OGD-510.017 [1 Units]
In Commercial Distribution
GS100627595000132 [Primary]
GS100627595000156 [Package]
Package: OGD-510.033 [1 Units]
In Commercial Distribution
GS100627595000194 [Package]
Contains: 00627595000156
Package: OGD-510.033+ACP085 [1 Units]
In Commercial Distribution
GS100627595000200 [Package]
Contains: 00627595000156
Package: OGD-510.033+ACP086 [1 Units]
In Commercial Distribution
GS100627595000491 [Package]
Package: OGD-510.028 [1 Units]
In Commercial Distribution
GS100627595000705 [Package]
Package: OGD-510.029 [1 Units]
In Commercial Distribution
GS100627595001269 [Package]
Package: OGD-510.031 [1 Units]
In Commercial Distribution
GS110627595000870 [Package]
Package: SOF-7547 [1 Units]
In Commercial Distribution
GS110627595000887 [Package]
Package: SOF-7548 [1 Units]
In Commercial Distribution
GS110627595000917 [Package]
Package: SOF-4319 [1 Units]
In Commercial Distribution
GS110627595000924 [Package]
Package: SOF-4320 [2 Units]
In Commercial Distribution
GS110627595000931 [Package]
Package: SOF-4321 [3 Units]
In Commercial Distribution
GS110627595000948 [Package]
Package: SOF-4322 [4 Units]
In Commercial Distribution
GS110627595000986 [Package]
Package: SOF-7152 [1 Units]
In Commercial Distribution
GS110627595001273 [Package]
Package: SOF-7540 [1 Units]
In Commercial Distribution
GS110627595001280 [Package]
Package: SOF-7541 [1 Units]
In Commercial Distribution
GS110627595001297 [Package]
Package: SOF-4598 [1 Units]
In Commercial Distribution
GS110627595001358 [Package]
Package: SOF-7542 [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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