AFIAS-50 FPRR022

GUDID 08806133010068

Boditech Med Inc.

Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD

• Primary Device ID: 08806133010068
• NIH Device Record Key: a8578f5c-e7de-425f-85e9-9819b87ba232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFIAS-50
• Version Model Number: FPRR022
• Catalog Number: FPRR022
• 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: true
• 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
• 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	08806133010068 [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: 2022-09-16
• Device Publish Date: 2017-10-19

Devices Manufactured by Boditech Med Inc.

• 08806133080849 - Swab-N-Go Home Test COVID-19 Ag: 2023-10-18
• 08806133010068 - AFIAS-50: 2022-09-16
• 08806133010068 - AFIAS-50: 2022-09-16
• 08806133010099 - ichroma Reader: 2022-06-10
• 08806133010136 - ALFIS-3: 2021-12-14 FLUOROMETER FOR CLINICAL USE
• 08806133005262 - AFIAS TSH-SP: 2020-06-17 AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic
• 08806133005279 - AFIAS TSH-VB: 2020-06-17 AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro d
• 08806679001520 - ichroma™ CRP: 2020-06-17
• 08806679002718 - ichroma™ iFOB: 2020-06-17