AFIAS iFOB with AFIAS-50 CFPO-15-1

GUDID 08806133005255

Faecal occult blood IVD, reagent

Primary Device ID	08806133005255
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	1
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

Device Issuing Agency	Device ID
GS1	08806133005255 [Primary]
GS1	18806133005252 [Unit of Use]

OOX	Automated Occult Blood Analyzer

Steralize Prior To Use	false
Device Is Sterile	false

00880613305255	CFPO-15-1
08806133005255	CFPO-15-1