AccessGUDID - DEVICE: BioFire® Blood Culture Identification 2 (BCID2) Panel (00815381020338)

GUDID

Device Identifier (DI) Information

Brand Name: BioFire® Blood Culture Identification 2 (BCID2) Panel
Version or Model: RFIT-ASY-0147
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOFIRE DIAGNOSTICS, LLC

Primary DI Number: 00815381020338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079280262 *Terms of Use

Device Description: IVD reagent kit containing 30 tests.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61308	Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PAM	Gram-Positive Bacteria And Their Resistance Markers
PEO	Fungal Organisms, Nucleic Acid-Based Assay
PEN	Gram-Negative Bacteria And Associated Resistance Markers

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193519	000
K243759	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8e484770-e245-48a4-8408-ab4ba0f5bf94
Public Version Date: February 06, 2025
Public Version Number: 4
DI Record Publish Date: July 02, 2020