FastPack SARS-CoV-2 IgG

Basic Information

• Brand Name: FastPack SARS-CoV-2 IgG
• Primary DI: 10816467020386
• Version / Model: SARS-CoV-2 IgG Immunoassay
• Catalog Number: 25000085
• Company Name: QUALIGEN INC.
• Labeler DUNS: 959103565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 90
• Record Status: Published
• Publish Date: 2020-08-05
• Public Version: 1
• Public Version Date: 2020-08-13
• Public Version Status: New
• Public Device Record Key: 614bee41-59eb-46ae-b007-b5db45777161

Device Description

90 Test Kit SARS-CoV-2 IgG Immunoassay

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: 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
QKO	Reagent, Coronavirus Serological	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
64760	SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	No	Active
64854	SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.	No	Active
64788	SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816467020389	GS1
Primary	10816467020386	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius