BioFire® Blood Culture Identification 2 (BCID2) Panel

GUDID 00815381020338

IVD reagent kit containing 30 tests.

BIOFIRE DIAGNOSTICS, LLC

Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

• Primary Device ID: 00815381020338
• NIH Device Record Key: 8e484770-e245-48a4-8408-ab4ba0f5bf94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioFire® Blood Culture Identification 2 (BCID2) Panel
• Version Model Number: RFIT-ASY-0147
• 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	00815381020338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193519

FDA Product Code

• PAM: Gram-Positive Bacteria And Their Resistance Markers

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: 2020-07-10
• Device Publish Date: 2020-07-02

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• 00815381020376 - BIOFIRE ® SPOTFIRE ® Module: 2023-04-14 Used IVD Instrument (SPOTFIRE® Module).
• 00815381020659 - BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel: 2023-04-14 IVD reagent kit containing 30 tests.