Catalog Number

00272

Brand Name

QuickVue

Version/Model Number

00272

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

K931761

Product Code

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Public Device Record Key

ea59511a-dcf0-4344-9eed-768fd71ef66c

Public Version Date

April 24, 2019

Public Version Number

1

DI Record Publish Date

April 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-