FDA.reportPublic FDA data

Sofia 2

Primary DI
30014613339755
Brand
Sofia 2
Company
QUIDEL CORPORATION
Model
20405
Catalog number
20405
Device description
Sofia 2 SARS Ag + FIA
Published
2023-03-28
Public version status
Update
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
QVFSimple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient SettingsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220039000
K233688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220039000Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation2023-03-08QVF
K233688000Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation2023-12-13QVF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50014613339759PackageGS112In Commercial Distribution
30014613339755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5001461333975950014613339759
3001461333975530014613339755

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a fluorescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
079509836
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30014613201090QuickVueOne-Step hCG Urine Test201092016-09-15
30014613339083Sofia20374203742021-02-17
30014613339229Sofia20377203772021-02-17
30014613339373QuickVue20387203872021-02-17
30014613337799Sofia20319203192019-12-10
30014613001782QuickVue+hCG S/U Test001782016-09-14
30014613001799QuickVue+hCG S/U Test001792016-09-14
30014613003434QuickVue In-Line00343003432018-11-10
30014613201083QuickVue20108201082018-11-10
30014613201106QuickVueOne-Step hCG Combo Test201102016-09-15
30014613201229QuickVue+20122201222018-11-10
30014613201250QuickVue20125201252018-11-10
30014613201939QuickVue20193201932018-11-10
30014613202011QuickVueiFOB Test202012016-09-15
30014613202059QuickVueiFOB Test202052016-09-15
30014613202189Sofia20218202182018-11-10
30014613202424Sofia20242202422018-11-10
30014613202547Sofia20254202542018-11-10
30014613202745Sofia20274202742018-11-10
30014613202981Sofia20298202982018-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816862028416WELLlife™WONDFO USA CO., LTD.QVF2026-06-01
00742860100673OSOM COVID-19 TestSEKISUI DIAGNOSTICS, LLCQVF2026-01-19
10742860100670OSOM COVID-19 TestSEKISUI DIAGNOSTICS, LLCQVF2026-01-19
00382902560920BD Veritor System for Rapid Detection of SARS-CoV-2BECTON, DICKINSON AND COMPANYQVF2025-08-21
30382902560921BD Veritor System for Rapid Detection of SARS-CoV-2BECTON, DICKINSON AND COMPANYQVF2025-08-21
B379COVAF201SCoV-2 Ag Detect™ Rapid TestINBIOS INTERNATIONAL, INCQVF2024-09-13
B379COVAF501SCoV-2 Ag Detect™ Rapid TestINBIOS INTERNATIONAL, INCQVF2024-09-13