Catalog Number

-

Brand Name

OraSure Quickflu Nasopharyngeal Wash / Aspirate

Version/Model Number

1001-0321

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K083746

Product Code

GNX

Product Code Name

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

Public Device Record Key

30d9a8d8-d626-4dcc-ab7c-10fe065ceed4

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

November 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-