AFIAS-6/SP Analyzer FPRR020-4

GUDID 00886133010075

AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with

Boditech Med Inc.

Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent

• Primary Device ID: 00886133010075
• NIH Device Record Key: bdf0f8da-ef9c-4a00-b6c6-beed72f0d357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFIAS-6/SP Analyzer
• Version Model Number: FPRR020-4
• Catalog Number: FPRR020-4
• Company DUNS: 689062203
• Company Name: Boditech Med 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886133010075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170232

FDA Product Code

• KHO: Fluorometer, For Clinical Use

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: 2018-07-06
• Device Publish Date: 2017-11-06

On-Brand Devices [AFIAS-6/SP Analyzer]

• 00886133010075: AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laborato
• 08806133010075: AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laborato