EliA SARS-CoV-2-Sp1 IgG Well

Basic Information

• Brand Name: EliA SARS-CoV-2-Sp1 IgG Well
• Primary DI: 07333066021287
• Version / Model: DECC066630
• Catalog Number: DECC066630
• Company Name: Phadia AB
• Labeler DUNS: 354019424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-21
• Public Version: 1
• Public Version Date: 2021-01-29
• Public Version Status: New
• Public Device Record Key: c1e61acb-5c8a-418f-b80f-537301e2d469

Device Description

EliA SARS-CoV-2-Sp1 IgG Well

Device Characteristics

• Single Use: No
• 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: 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
64836	SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent 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) the causative agent of coronavirus disease (COVID-19), in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07333066021201	GS1		4	In Commercial Distribution
Primary	07333066021287	GS1

Customer Contacts

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

Storage Conditions

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