Catalog Number

-

Brand Name

BioFire® Blood Culture Identification 2 (BCID2) Panel

Version/Model Number

RFIT-ASY-0147

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

K193519

Product Code

PAM

Product Code Name

Gram-Positive Bacteria And Their Resistance Markers

Public Device Record Key

8e484770-e245-48a4-8408-ab4ba0f5bf94

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

July 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-