Catalog Number

FLM1-ASY-0001R

Brand Name

FilmArray® Instrument

Version/Model Number

FLM1-ASY-0001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2021

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

K103175

Product Code

NSU

Product Code Name

Instrumentation For Clinical Multiplex Test Systems

Public Device Record Key

bedba94b-480f-49cd-88b2-10ad1ea04a1b

Public Version Date

September 16, 2022

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

-