ORAcollect Dx

GUDID 10627595000313

DNA Specimen Collection, Saliva

DNA Genotek Inc

Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab
Primary Device ID10627595000313
NIH Device Record Key60698651-346b-4865-ae1a-e65ebb8eea59
Commercial Distribution StatusIn Commercial Distribution
Brand NameORAcollect Dx
Version Model NumberOCD-100A
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-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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100627595000316 [Primary]
GS100627595001009 [Package]
Contains: 00627595000316
Package: OCD-100A.022 [1 Units]
In Commercial Distribution
GS100627595001023 [Package]
Contains: 00627595000316
Package: OCD-100A.023 [1 Units]
In Commercial Distribution
GS100627595001047 [Package]
Contains: 00627595000316
Package: OCD-100A.024 [1 Units]
In Commercial Distribution
GS100627595001061 [Package]
Contains: 00627595000316
Package: OCD-100A.025 [1 Units]
In Commercial Distribution
GS110627595000313 [Package]
Contains: 00627595000316
Package: Reclosable Bag [25 Units]
In Commercial Distribution
GS110627595001013 [Package]
Contains: 00627595001009
Package: OCD-100A.022+ACP128 [25 Units]
In Commercial Distribution
GS110627595001037 [Package]
Contains: 00627595001023
Package: OCD-100A.023+ACP129 [25 Units]
In Commercial Distribution
GS110627595001051 [Package]
Contains: 00627595001047
Package: OCD-100A.024+ACP130 [25 Units]
In Commercial Distribution
GS110627595001075 [Package]
Contains: 00627595001061
Package: OCD-100A.025+ACP131 [25 Units]
In Commercial Distribution

FDA Product Code

OYJDna Specimen Collection, Saliva

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-28
Device Publish Date2022-11-18

On-Brand Devices [ORAcollect Dx]

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

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