FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104

GUDID 00815381020116

IVD reagent kit containing 6 tests.

BIOFIRE DIAGNOSTICS, LLC

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• Primary Device ID: 00815381020116
• NIH Device Record Key: dfdbf4ad-001c-4cc5-995a-83e7c4d8fac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FilmArray® Gastrointestinal (GI) Panel
• Version Model Number: RFIT-ASY-0104
• Catalog Number: RFIT-ASY-0104
• 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	00815381020116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140407

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-08
• Device Publish Date: 2016-09-23

On-Brand Devices [FilmArray® Gastrointestinal (GI) Panel]

• 00815381020116: IVD reagent kit containing 6 tests.
• 00815381020109: IVD reagent kit containing 30 tests.