ORAcollect Dx

GUDID 00627595000309

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 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 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 Specimen stabilization reagent IVD Specimen stabilization reagent IVD
Primary Device ID00627595000309
NIH Device Record Key4f3538d2-4ec0-427c-bbc9-39172bff38e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameORAcollect Dx
Version Model NumberOCD-100
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
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 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 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100627595000040 [Package]
Package: OCD-100.032 [1 Units]
In Commercial Distribution
GS100627595000057 [Package]
Package: OCD-100.034 [1 Units]
In Commercial Distribution
GS100627595000163 [Package]
Contains: 00627595000040
Package: OCD-100.032+ACP103 [25 Units]
In Commercial Distribution
GS100627595000170 [Package]
Package: OCD-100.034+ACP099 [25 Units]
In Commercial Distribution
GS100627595000309 [Primary]
GS100627595000835 [Package]
Package: OCD-100.035 [1 Units]
In Commercial Distribution
GS100627595001085 [Package]
Package: OCD-100.033 [1 Units]
In Commercial Distribution
GS100627595001108 [Package]
Package: OCD-100.008 [1 Units]
In Commercial Distribution
GS110627595000047 [Package]
Contains: 00627595000040
Package: OCD-100.032 Reclobag [25 Units]
In Commercial Distribution
GS110627595000078 [Package]
Package: OCD-100+ACP041 [10 Units]
In Commercial Distribution
GS110627595000306 [Package]
Package: Reclosable Bag [25 Units]
In Commercial Distribution
GS110627595000832 [Package]
Contains: 00627595000835
Package: OCD-100.035+ACP140 [10 Units]
In Commercial Distribution
GS110627595000856 [Package]
Package: SOF-1015 [1 Units]
In Commercial Distribution
GS110627595000863 [Package]
Package: OCD-100+ACP126 [1 Units]
In Commercial Distribution
GS110627595000955 [Package]
Package: OCD-100+ACP127 [25 Units]
In Commercial Distribution
GS110627595000993 [Package]
Package: SOF-4814 [1 Units]
In Commercial Distribution
GS110627595001099 [Package]
Package: SOF-1011 [1 Units]
In Commercial Distribution
GS110627595001112 [Package]
Contains: 00627595001108
Package: OCD-100.008+ACP096 [25 Units]
In Commercial Distribution
GS110627595001327 [Package]
Package: OCD-100+ACP125 [25 Units]
In Commercial Distribution
GS110627595001365 [Package]
Package: SOF-1017 [1 Units]
In Commercial Distribution
GS110627595001372 [Package]
Package: SOF-1018 [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 Date2016-09-10

On-Brand Devices [ORAcollect Dx]

00627595000309DNA Specimen Collection, Saliva
10627595000825DNA Specimen Collection, Saliva
10627595000313DNA Specimen Collection, Saliva
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