OraSure Oral Fluid Collection Device

GUDID 20608337000119

Orasure Technologies, Inc.

Oral specimen transport medium collection kit Oral specimen transport medium collection kit Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Saliva/oral specimen collection kit, transport medium Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit
Primary Device ID20608337000119
NIH Device Record Keyadc041dd-1d9c-4110-81a9-ebbc69fd5576
Commercial Distribution StatusIn Commercial Distribution
Brand NameOraSure Oral Fluid Collection Device
Version Model Number3001-2870
Company DUNS114152184
Company NameOrasure Technologies, Inc.
Device Count1
DM Exempttrue
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

Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100608337000115 [Primary]
GS110608337000112 [Package]
Contains: 00608337000115
Package: carton [50 Units]
In Commercial Distribution
GS120608337000119 [Package]
Contains: 00608337000115
Package: carton [500 Units]
In Commercial Distribution

FDA Product Code

PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-15

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