Catalog Number

PRD-04338

Brand Name

PANTHER FUSION

Version/Model Number

AMR CTRLS, PANTHER FUSION, IVD

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

K172629

Product Code

OCC

Product Code Name

Respiratory virus panel nucleic acid assay system

Public Device Record Key

2266f372-2e66-40f4-a2bd-59da8b7deb42

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

December 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-