AFIAS-6/SP Analyzer FPRR020-4

GUDID 08806133010075

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 various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in serum or plasma samples.

Boditech Med Inc.

Thyroid stimulating hormone (TSH) IVD, reagent

• Primary Device ID: 08806133010075
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806133010075 [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: 4
• Public Version Date: 2019-12-13
• 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