Access TSH (3rd IS) C28643

GUDID 15099590744373

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results.

Beckman Coulter, Inc.

Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590744373
• NIH Device Record Key: c48f54f5-a023-4cbb-8ee5-83898c9de59c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access TSH (3rd IS)
• Version Model Number: C28643
• Catalog Number: C28643
• 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	15099590744373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221225

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: 2
• Public Version Date: 2023-07-26
• Device Publish Date: 2022-12-31

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