Catalog Number

303123

Brand Name

PRODESSE

Version/Model Number

PROFLU+ ASSAY KIT, 1,500 REACTIONS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 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

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

K132129

Product Code

OCC

Product Code Name

Respiratory virus panel nucleic acid assay system

Public Device Record Key

bea9645f-a5f1-4f3a-b301-1a3a3a70178b

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

April 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-