OraSure Quickflu Nasopharyngeal Wash / Aspirate

GUDID 00608337000047

Orasure Technologies, Inc.

Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent Influenza A/B virus antigen IVD, reagent
Primary Device ID00608337000047
NIH Device Record Key30d9a8d8-d626-4dcc-ab7c-10fe065ceed4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOraSure Quickflu Nasopharyngeal Wash / Aspirate
Version Model Number1001-0321
Company DUNS114152184
Company NameOrasure Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100608337000047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C

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 Date2016-11-25

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20608337000065 - OraSure Quick Flu 22-Count Flu A + B Kit2018-07-06
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20608337000010 - OraQuick Advance Rapid HIV 1/2 Antibody Test2018-07-06

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