Access EPO Calibrators A16365

GUDID 15099590201845

The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (

Beckman Coulter, Inc.

Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590201845
• NIH Device Record Key: 4fb7cd0e-f5d8-4898-aff9-70a268ce8ad4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access EPO Calibrators
• Version Model Number: A16365
• Catalog Number: A16365
• 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	15099590201845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052223

FDA Product Code

• JIT: Calibrator, Secondary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-09
• Device Publish Date: 2016-09-09

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