BD Veritor™ System For Rapid Detection of Group A Strep - CLIA waived kit

Basic Information

• Brand Name: BD Veritor™ System For Rapid Detection of Group A Strep - CLIA waived kit
• Primary DI: 00382902560401
• Version / Model: 256040
• Catalog Number: 256040
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 9ab8ff68-578a-4102-bded-99a2f03ff154

Device Description

BD Veritor™ System For Rapid Detection of Group A Strep Contains: 30 Strep A Devices, 30 GAS Reagent 2 in unitized tubes, 30 individually wrapped, sterile throat swabs, one 4 mL dropper bottle GAS Reagent 1, one each of positive and negative control swabs

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
GTY	ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51707	Beta-haemolytic Group A Streptococcus 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 Group A beta-haemolytic Streptococcus bacteria 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	00382902560401	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122718	000

Storage Conditions

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