BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit

Basic Information

• Brand Name: BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit
• Primary DI: 00382902560418
• Version / Model: 256041
• Catalog Number: 256041
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-02
• Public Version: 4
• Public Version Date: 2023-11-22
• Public Version Status: Update
• Public Device Record Key: 394f0e76-574e-4a22-80e1-4c019a6d09ab

Device Description

Kit Flu A+B 30 Test Hospital Veritor

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
PSZ	Devices detecting influenza A, B, and C virus antigens	Microbiology	866.3328	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49119	Influenza A/B virus 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 influenza A virus and/or influenza B virus 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
Primary	00382902560418	GS1
Package	05032902560417	GS1	Case	12	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120049	000
K121797	000
K132256	000
K132693	000
K133138	000
K151301	000
K152874	000
K160164	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius