Catalog Number

00345

Brand Name

QuickVue In-Line

Version/Model Number

00345

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

K945080

Product Code

GTY

Product Code Name

ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Public Device Record Key

34129767-a725-4d4e-9077-b9996f1a60bd

Public Version Date

March 29, 2019

Public Version Number

1

DI Record Publish Date

March 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-