Anti-SARS-CoV-2 ELISA (IgA)

Basic Information

• Brand Name: Anti-SARS-CoV-2 ELISA (IgA)
• Primary DI: 04049016145547
• Version / Model: EI 2606-9601 A
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Labeler DUNS: 322209263
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-22
• Public Version: 2
• Public Version Date: 2020-09-24
• Public Version Status: Update
• Public Device Record Key: 6bc0e0e0-7b83-4888-991e-92d9dddd4f07
• Distribution End Date: 2020-09-23

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: 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
64830	SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049016145547	GS1

Storage Conditions

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