FREND TSH FRTS 025

GUDID 08809317540016

It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.

NanoEnTek, Inc.

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

• Primary Device ID: 08809317540016
• NIH Device Record Key: 5743c7cb-79b8-47e4-986a-4d829af57858
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREND TSH
• Version Model Number: FRTS 025
• Catalog Number: FRTS 025
• Company DUNS: 687910463
• Company Name: NanoEnTek, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	08809317540016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131928

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: 4
• Public Version Date: 2024-07-22
• Device Publish Date: 2016-09-30

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• 08809317540016 - FREND TSH: 2024-07-22It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.
• 08809317540016 - FREND TSH: 2024-07-22 It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.
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