Gazelle PathoCatch

Basic Information

• Brand Name: Gazelle PathoCatch
• Primary DI: 08908016644022
• Version / Model: MGPF25
• Catalog Number: MGPF25
• Company Name: MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
• Labeler DUNS: 860396703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-09
• Public Version: 1
• Public Version Date: 2021-11-17
• Public Version Status: New
• Public Device Record Key: 48453e87-2479-4d6e-8799-04aa977f5841
• Distribution End Date: 2030-12-31

Device Description

COVID-19 Antigen Fluorescence Immunoassay Kit

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
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
Primary	08908016644022	GS1