AFIAS iFOB with AFIAS-50 CFPO-15-1

GUDID 00880613305255

Boditech Med Inc.

Faecal occult blood IVD, reagent

• Primary Device ID: 00880613305255
• NIH Device Record Key: 89cc0c79-aec5-4121-bbfc-e3c6da2f9773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFIAS iFOB with AFIAS-50
• Version Model Number: CFPO-15-1
• Catalog Number: CFPO-15-1
• Company DUNS: 689062203
• Company Name: Boditech Med Inc.
• Device Count: 25
• DM Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880613305255 [Primary]
GS1	08806133005256 [Unit of Use]

FDA Product Code

• OOX: Automated Occult Blood Analyzer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-22

On-Brand Devices [AFIAS iFOB with AFIAS-50]

• 00880613305255: CFPO-15-1
• 08806133005255: CFPO-15-1