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

Basic Information

• Brand Name: BD Veritor System for Rapid Detection of SARS-CoV-2
• Primary DI: 00382902560920
• Version / Model: 256092
• Catalog Number: 256092
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-21
• Public Version: 2
• Public Version Date: 2026-04-17
• Public Version Status: Update
• Public Device Record Key: 7ef5953d-6ff4-4596-993c-8a2bfd567402

Device Description

Veritor SARS-CoV2 assay Gen 2

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: Yes
• 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
QVF	Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings	Microbiology	866.3982	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64912	SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30382902560921	GS1	Pack or Inner Pack	12	In Commercial Distribution
Primary	00382902560920	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K243872	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry