Catalog Number

20121

Brand Name

QuickVue+

Version/Model Number

Mononucleosis Test

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

K902510

Product Code

KTN

Product Code Name

SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Public Device Record Key

2a5b89dd-95a9-4bf2-a01f-8211f96333b5

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-