Access SARS-CoV-2 IgG Calibrator C58963

GUDID 15099590738655

The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.

Beckman Coulter, Inc.

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

• Primary Device ID: 15099590738655
• NIH Device Record Key: db839804-bd86-4aaa-9273-99810b1115dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access SARS-CoV-2 IgG Calibrator
• Version Model Number: C58963
• Catalog Number: C58963
• 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	15099590738655 [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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