FDA.reportPublic FDA data

BioFire® COVID-19 Test 2

Primary DI
00851458005228
Brand
BioFire® COVID-19 Test 2
Company
BIOFIRE DEFENSE, LLC
Model
DFA2-ASY-0015
Catalog number
DFA2-ASY-0015
Device description
BioFire® COVID-19 Test 2 - IVD reagent kit containing 6 tests
Published
2023-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211079000
K221460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211079000BioFire COVID-19 Test 2Biofire Defense, LLC2021-11-01QQX
K221460000BioFire COVID-19 Test 2Biofire Defense, LLC2022-07-25QQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851458005228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851458005228008514580052288514580052280851458005228

GMDN Terms#

Term, Definition table
TermDefinition
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-262-3592support@biofiredefense.com

Regulatory Flags#

DUNS number
556915205
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851458005327SPOTFIRE Control Station - ITARFAST-ASY-0001-AFAST-ASY-0001-A2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARFAST-ASY-0001-BFAST-ASY-0001-B2025-12-16
00851458005303BioFire Warrior PanelNGDS-ASY-0018NGDS-ASY-00182025-08-10
00851458005310BioFire Warrior Panel Control KitDFA2-ASY-0047DFA2-ASY-00472025-08-10
00851458005297FILMARRAY® COMMERCIAL LAPTOPCOMP-SUB-0034COMP-SUB-00342024-03-19
00851458005051FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0002NGDS-ASY-00022017-10-27
00851458005112FILMARRAY1.5FLM1-ASY-01212016-09-22
00851458005129FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0002NGDS-ASY-0002U2017-10-27
00851458005143FilmArray® 2.0 Instrument NGDS ConfigurationNGDS-ASY-0004NGDS-ASY-00042017-12-15
00851458005266FILMARRAY NGDS WARRIOR PANEL - CADFA2-ASY-0012DFA2-ASY-00122024-06-20
00851458005273BioFire® Global Fever Special Pathogens PanelDFA2-ASY-0018DFA2-ASY-00182023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneDFA2-ASY-0019DFA2-ASY-00192023-08-31
00851458005099NGDSNGDS-ASY-0006NGDS-ASY-00062017-04-21
00851458005136FilmArray® NGDS Warrior PanelNGDS-ASY-0007NGDS-ASY-00072017-10-24
00851458005242BioFire® Global Fever Panel DFA2-ASY-0004DFA2-ASY-00042021-07-16
00851458005259BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel DFA2-ASY-0006DFA2-ASY-00062021-07-16
00851458005235BioFire® COVID-19 Test 2DFA2-ASY-0016DFA2-ASY-00162023-02-16
00851458005020JBAIDSJRPD-ASY-0124JRPD-ASY-01242016-09-07
00851458005006JBAIDSJB01JRPD-ASY-00012016-09-07
00851458005013JBAIDSJRPD-ASY-0016JRPD-ASY-00162016-09-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20816101027136Simplexa COVID-19 Positive Control GEN II Pack DIASORIN MOLECULAR LLCQQX2025-09-17
15420045516991Aptima®Hologic, Inc.QQX2025-03-14
15420045517004Aptima®Hologic, Inc.QQX2025-03-14
15420045517035Aptima®Hologic, Inc.QQX2025-03-14
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019422Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay KitLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
80190302019438Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019446Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR ControlLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
07332940008581GeneXpert®CEPHEIDQQX2024-01-22
00382904453619BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-12-09
00382904453732BD Respiratory Viral Panel for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-09-28
00875197006841cobas® SARS-CoV-2 Qualitative 192TRoche Molecular Systems, Inc.QQX2023-09-12
00875197006858cobas® SARS-CoV-2 Qualitative Control KitRoche Molecular Systems, Inc.QQX2023-09-12
00875197006933cobas® SARS-CoV-2 Qualitative 480TRoche Molecular Systems, Inc.QQX2023-09-12
20816101027020Simplexa COVID-19 DirectDIASORIN MOLECULAR LLCQQX2023-06-16
20816101027037Simplexa COVID-19 Positive Control PackDIASORIN MOLECULAR LLCQQX2023-06-16
00851458005235BioFire® COVID-19 Test 2BIOFIRE DEFENSE, LLCQQX2023-02-16
06973342000530COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-02-02
06973342000158COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-01-30
10789594001002MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001088MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001095MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001101MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001354MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001361MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
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