FilmArray® Respiratory Panel (RP) - IVD reagent kit containing 6 tests. - BIOFIRE DIAGNOSTICS, LLC

Duns Number:079280262

Device Description: IVD reagent kit containing 6 tests.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

RFIT-ASY-0125

Brand Name

FilmArray® Respiratory Panel (RP)

Version/Model Number

RFIT-ASY-0125

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

OCC

Product Code Name

Respiratory Virus Panel Nucleic Acid Assay System

Device Record Status

Public Device Record Key

f2a3fc64-9cf1-4ca3-8a7c-3b38984d57f8

Public Version Date

March 25, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOFIRE DIAGNOSTICS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 31