Access SARS-CoV-2 IgM QC

Basic Information

• Brand Name: Access SARS-CoV-2 IgM QC
• Primary DI: 15099590738631
• Version / Model: C58959
• Catalog Number: C58959
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-04
• Public Version: 1
• Public Version Date: 2022-05-12
• Public Version Status: New
• Public Device Record Key: 31e82a9b-ea5d-4253-b349-1ded86c13299

Device Description

The Access SARS-CoV-2 IgM QC is intended for monitoring system performance of the Access SARS-CoV-2 IgM assay. The Access SARS-CoV-2 IgM QC is for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgM QC are only for use under the Food and Drug Administration's Emergency Use Authorization.

Device Characteristics

• Single Use: No
• 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: 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
QKO	Reagent, Coronavirus Serological	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
64977	SARS-CoV-2 immunoglobulin M (IgM) 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 M (IgM) 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
Primary	15099590738631	GS1