Catalog Number

-

Brand Name

BioFire® Respiratory Panel 2.1 EUA

Version/Model Number

423738

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2022

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

-

Product Code

QJR

Product Code Name

Reagents, 2019-Novel Coronavirus Nucleic Acid

Public Device Record Key

acd685b4-c0b1-458b-b267-4be17b47f0f2

Public Version Date

July 28, 2022

Public Version Number

5

DI Record Publish Date

November 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-