BioFire® COVID-19 Test 2

Basic Information

• Brand Name: BioFire® COVID-19 Test 2
• Primary DI: 00851458005235
• Version / Model: DFA2-ASY-0016
• Catalog Number: DFA2-ASY-0016
• Company Name: BIOFIRE DEFENSE, LLC
• Labeler DUNS: 556915205
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-16
• Public Version: 1
• Public Version Date: 2023-02-24
• Public Version Status: New
• Public Device Record Key: bf8b7ffb-22f3-4cfc-8132-b5a0ca18a387

Device Description

BioFire® COVID-19 Test 2 - IVD reagent kit containing 30 tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	866.3981	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64747	SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851458005235	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211079	000
K221460	000