Access TSH (3rd IS) Calibrators B63285

GUDID 15099590671501

The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3rd IS) assay for the quantitative determination of human thyroid-stimul

Beckman Coulter, Inc.

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

• Primary Device ID: 15099590671501
• NIH Device Record Key: 9b852b00-cdc0-4b2d-bbc3-5479ec80eb4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access TSH (3rd IS) Calibrators
• Version Model Number: B63285
• Catalog Number: B63285
• 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	15099590671501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153651

FDA Product Code

• JIS: Calibrator, Primary

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

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