Catalog Number

RFIT-ASY-0119

Brand Name

FilmArray® Meningitis/Encephalitis (ME) Panel

Version/Model Number

RFIT-ASY-0119

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

DEN150013,K160462

Product Code

PLO

Product Code Name

Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

Public Device Record Key

b8e67541-affd-4aa0-8841-4eb027a63894

Public Version Date

December 21, 2020

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-