BioFire® COVID-19 Test 2 DFA2-ASY-0015

GUDID 00851458005228

BioFire® COVID-19 Test 2 - IVD reagent kit containing 6 tests

BIOFIRE DEFENSE, LLC

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00851458005228
• NIH Device Record Key: 210953de-37a9-4795-82a1-9227047e32ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioFire® COVID-19 Test 2
• Version Model Number: DFA2-ASY-0015
• Catalog Number: DFA2-ASY-0015
• Company DUNS: 556915205
• Company Name: BIOFIRE DEFENSE, 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

Customer Support Contacts

• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851458005228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211079

FDA Product Code

• QQX: Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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: 2023-02-24
• Device Publish Date: 2023-02-16

On-Brand Devices [BioFire® COVID-19 Test 2]

• 00851458005235: BioFire® COVID-19 Test 2 - IVD reagent kit containing 30 tests
• 00851458005228: BioFire® COVID-19 Test 2 - IVD reagent kit containing 6 tests