Catalog Number

RFIT-ASY-0120

Brand Name

FilmArray® Respiratory Panel (RP) EZ

Version/Model Number

RFIT-ASY-0120

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 08, 2021

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

K152579

Product Code

OCC

Product Code Name

Respiratory Virus Panel Nucleic Acid Assay System

Public Device Record Key

61e67b33-a151-409a-a818-5d9b00fcfed9

Public Version Date

May 03, 2022

Public Version Number

6

DI Record Publish Date

December 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-