Catalog Number

RFIT-ASY-0136

Brand Name

FilmArray® Respiratory Panel 2 plus (RP2plus)

Version/Model Number

RFIT-ASY-0136

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 27, 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

NSU

Product Code Name

Instrumentation For Clinical Multiplex Test Systems

Public Device Record Key

444bd058-f904-485f-b284-9f950df7d34b

Public Version Date

July 28, 2022

Public Version Number

6

DI Record Publish Date

December 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-