ACTIVE Aldosterone RIA DSL8600

GUDID 15099590211592

Radioimmunoassay Kit for the quantitative measurement of aldosterone in human serum, plasma or urine.

Beckman Coulter, Inc.

Aldosterone IVD, kit, radioimmunoassay

• Primary Device ID: 15099590211592
• NIH Device Record Key: 9d2fe13b-ded0-4b6a-8acf-4d736b7460d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIVE Aldosterone RIA
• Version Model Number: DSL8600
• Catalog Number: DSL8600
• 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	15099590211592 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943397

FDA Product Code

• CJM: Radioimmunoassay, Aldosterone

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: 2019-12-05
• Device Publish Date: 2016-09-09

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