Access Unconjugated Estriol Calibrators 33575

GUDID 15099590231149

The Access Unconjugated Estriol Calibrators are intended to calibrate the Access Unconjugated Estriol assay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590231149
• NIH Device Record Key: 1897079f-4373-4fc5-9c55-9ee246ffa392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Unconjugated Estriol Calibrators
• Version Model Number: 33575
• Catalog Number: 33575
• 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	15099590231149 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

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: 2021-10-01
• Device Publish Date: 2021-09-23

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