Access SARS-CoV-2 IgM QC C58959

GUDID 15099590738631

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.

Beckman Coulter, Inc.

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, control

• Primary Device ID: 15099590738631
• NIH Device Record Key: 31e82a9b-ea5d-4253-b349-1ded86c13299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access SARS-CoV-2 IgM QC
• Version Model Number: C58959
• Catalog Number: C58959
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590738631 [Primary]

FDA Product Code

• QKO: Reagent, Coronavirus Serological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-12
• Device Publish Date: 2022-05-04

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