BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid

GUDID 00815381020888

IVD reagent kit containing 30 tests.

BIOFIRE DIAGNOSTICS, LLC

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00815381020888
• NIH Device Record Key: c2a2167f-ab31-432a-b7d9-115af3ce11aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid
• Version Model Number: 424898
• Company DUNS: 079280262
• Company Name: BIOFIRE DIAGNOSTICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815381020888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243885

FDA Product Code

• PCH: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-26
• Device Publish Date: 2025-02-18

On-Brand Devices [BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid]

• 00815381020963: IVD reagent kit containing 6 tests.
• 00815381020888: IVD reagent kit containing 30 tests.