Catalog Number

-

Brand Name

Acucy Flu Test Kit

Version/Model Number

1010

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

PSZ

Product Code Name

Devices Detecting Influenza A, B, And C Virus Antigens

Public Device Record Key

2fce869c-cd5d-41ab-9736-f7968653e8b2

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-