ichroma™ iFOB CFPC-15

GUDID 08806679002718

Faecal occult blood IVD, reagent

Primary Device ID	08806679002718
NIH Device Record Key	c9dd660a-e75d-471c-9979-b43b1e4bdb75
Commercial Distribution Status	In Commercial Distribution
Brand Name	ichroma™ iFOB
Version Model Number	CFPC-15
Catalog Number	CFPC-15
Company DUNS	689062203
Company Name	Boditech Med Inc.
Device Count	25
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	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	08806679002718 [Primary]
GS1	18806679002715 [Unit of Use]

OOX	Automated Occult Blood Analyzer

Steralize Prior To Use	false
Device Is Sterile	false

08806133080849 - Swab-N-Go Home Test COVID-19 Ag	2023-10-18
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
08806679002718 - ichroma™ iFOB	2020-06-17

Mark Image Registration \| Serial	Company Trademark Application Date
ICHROMA 86472614 4976000 Live/Registered	BODITECH MED INC. 2014-12-05