AccessGUDID - DEVICE: BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid (00815381020888)

GUDID

Device Identifier (DI) Information

Brand Name: BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid
Version or Model: 424898
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOFIRE DIAGNOSTICS, LLC

Primary DI Number: 00815381020888
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?
61058	Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243885	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: c2a2167f-ab31-432a-b7d9-115af3ce11aa
Public Version Date: February 26, 2025
Public Version Number: 1
DI Record Publish Date: February 18, 2025