Catalog Number

TF8147

Brand Name

Fluoro-CheckTM Influenza A+B

Version/Model Number

TF8147

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PSZ

Product Code Name

Devices Detecting Influenza A, B, And C Virus Antigens

Public Device Record Key

2f4d5839-a734-4d4c-bb8b-d9c83ea821a2

Public Version Date

June 03, 2019

Public Version Number

1

DI Record Publish Date

May 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-