Catalog Number

RFIT-ASY-0126

Brand Name

FilmArray® BCID Panel

Version/Model Number

RFIT-ASY-0126

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

K130914,K143171,K160457,K181493

Product Code

OOI

Product Code Name

Real Time Nucleic Acid Amplification System

Public Device Record Key

b944bfdd-2aed-429f-bb12-69d86315ec0b

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

-