Access TSH (3rd IS) B63284

GUDID 15099590671495

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating

Beckman Coulter, Inc.

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• Primary Device ID: 15099590671495
• NIH Device Record Key: cdacfef1-2248-4b5e-81e6-354f371e786c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access TSH (3rd IS)
• Version Model Number: B63284
• Catalog Number: B63284
• 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	15099590671495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153651

FDA Product Code

• JLW: Radioimmunoassay, Thyroid-Stimulating Hormone

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: 2016-09-28

On-Brand Devices [Access TSH (3rd IS)]

• 15099590671495: The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the q
• 15099590744373: The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the q