Catalog Number

20254

Brand Name

Sofia

Version/Model Number

20254

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

K112177

Product Code

GNX

Product Code Name

ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

Public Device Record Key

f04e3c43-604c-46e5-813d-4f61fcd752f3

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

-