Catalog Number

-

Brand Name

Acucy System

Version/Model Number

1039

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2019

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

-

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

87305a6f-26b9-4e80-a161-d64e40b2d6bf

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-