Total Immunoglobulin E (IgE)

GUDID 15099590701727

Total Immunoglobulin E (IgE) Reagent kit for AU/DxC AU clinical chemistry analyzers.

Beckman Coulter, Inc.

Total immunoglobulin E (IgE total) IVD, antibody

• Primary Device ID: 15099590701727
• NIH Device Record Key: bac6d46c-cea7-4391-95dd-4207ae21d9c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Immunoglobulin E (IgE)
• Version Model Number: C22529
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	15099590701727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220178

FDA Product Code

• DGC: Ige, Antigen, Antiserum, Control

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: 2022-05-11
• Device Publish Date: 2022-05-03

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