Catalog Number

PRD-04337

Brand Name

PANTHER FUSION

Version/Model Number

PARAFLU CTRLS KIT, 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

K172282

Product Code

OOU

Product Code Name

Parainfluenza multiplex nucleic acid assay

Public Device Record Key

21346606-f2ce-44a1-a833-80bfcacc0ce0

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-