AFIAS TSH-VB SMFP-58

GUDID 08806133005279

AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid indiciduals.

Boditech Med Inc.

Thyroid stimulating hormone (TSH) IVD, reagent

• Primary Device ID: 08806133005279
• NIH Device Record Key: 0d915ff1-b84f-4d5e-9cc6-eafd04ee2dba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFIAS TSH-VB
• Version Model Number: AFIAS TSH-VB
• Catalog Number: SMFP-58
• Company DUNS: 689062203
• Company Name: Boditech Med Inc.
• Device Count: 24
• 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

Customer Support Contacts

• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806133005279 [Primary]
GS1	18806133005276 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170232

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: 2020-06-17
• Device Publish Date: 2017-11-06

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