Catalog Number

FLM1-ASY-0121

Brand Name

FILMARRAY

Version/Model Number

1.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2017

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

-

Prescription Use (Rx)

-

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

6de9136a-4f09-4996-ae1b-17dc025c4c0d

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-