Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)

Basic Information

• Brand Name: Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
• Primary DI: 00810172700093
• Version / Model: Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
• Company Name: WatMIND USA
• Labeler DUNS: 117617770
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-08
• Public Version: 1
• Public Version Date: 2024-08-16
• Public Version Status: New
• Public Device Record Key: 8f125626-18b4-45c4-8564-999d02ef61ae

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	866.3984	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64787	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 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), 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	00810172700093	GS1