Catalog Number

00343

Brand Name

QuickVue In-Line

Version/Model Number

00343

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

-

Product Code

GTZ

Product Code Name

ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.

Public Device Record Key

54a15936-b2af-4f6f-9e0b-4a72e398ff53

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-