Catalog Number

RFIT-ASY-0104

Brand Name

FilmArray® Gastrointestinal (GI) Panel

Version/Model Number

RFIT-ASY-0104

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

K140407,K143005,K160459

Product Code

PCH

Product Code Name

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Public Device Record Key

dfdbf4ad-001c-4cc5-995a-83e7c4d8fac0

Public Version Date

December 21, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-