Genabio COVID-19 Rapid Self-Test Kit

Basic Information

• Brand Name: Genabio COVID-19 Rapid Self-Test Kit
• Primary DI: 00196852195008
• Version / Model: RA9-E00325
• Company Name: Genabio Diagnostics Inc.
• Labeler DUNS: 118586095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-08-07
• Public Version: 1
• Public Version Date: 2022-08-15
• Public Version Status: New
• Public Device Record Key: 4de71441-630e-4f71-b830-436ca97effc1

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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QKP	Coronavirus Antigen Detection Test System.	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
64829	SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, within a short period, relative to standard laboratory testing procedures, using a fluorescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses to aid the diagnosis of coronavirus disease (COVID-19) infection. It is not intended to be used for self-testing.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00196852254316	GS1
Primary	00196852195008	GS1