Catalog Number

DFA2-ASY-0006

Brand Name

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel

Version/Model Number

DFA2-ASY-0006

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

K202382

Product Code

PMN

Product Code Name

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Public Device Record Key

4ce4946c-7539-48a4-9f67-a962a458f317

Public Version Date

July 26, 2021

Public Version Number

1

DI Record Publish Date

July 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-