FDA.reportPublic FDA data

BD Veritor System for Rapid Detection of SARS-CoV-2

Primary DI
00382902560920
Brand
BD Veritor System for Rapid Detection of SARS-CoV-2
Company
BECTON, DICKINSON AND COMPANY
Model
256092
Catalog number
256092
Device description
Veritor SARS-CoV2 assay Gen 2
Published
2025-08-21
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
K243872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243872000BD Veritor System for SARS-CoV-2Becton, Dickinson and Company2025-06-16QVF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902560921PackageGS112In Commercial Distribution
00382902560920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290256092130382902560921
00382902560920003829025609203829025609200382902560920

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 1 and 2 (SARS-CoV-1/SARS-CoV-2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
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
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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
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
30014613339755Sofia 2QUIDEL CORPORATIONQVF2023-03-28