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
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479285723McKessonMCKESSON MEDICAL-SURGICAL INC.QVF2026-06-18
20612479285747McKessonMCKESSON MEDICAL-SURGICAL INC.QVF2026-06-18
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