Catalog Number

RFIT-ASY-0130

Brand Name

FilmArray® Respiratory Panel 2 (RP2)

Version/Model Number

RFIT-ASY-0130

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 20, 2022

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

-

Product Code

OCC

Product Code Name

Respiratory Virus Panel Nucleic Acid Assay System

Public Device Record Key

274c8e71-d3b2-4bb5-8469-50b7d089d26e

Public Version Date

July 28, 2022

Public Version Number

5

DI Record Publish Date

July 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-