ichroma Reader FPRR001

GUDID 08806133032008

Boditech Med Inc.

Faecal occult blood immunoassay analyser IVD, semi-automated
Primary Device ID08806133032008
NIH Device Record Key74b93905-e7cd-4f14-a240-c093d3915334
Commercial Distribution StatusIn Commercial Distribution
Brand Nameichroma Reader
Version Model NumberFPRR001
Catalog NumberFPRR001
Company DUNS689062203
Company NameBoditech Med Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com
Phone732-9180770
Emailagenffon@immunostics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806133032008 [Primary]

FDA Product Code

OOXAutomated Occult Blood Analyzer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-03-03
Device Publish Date2017-10-26

On-Brand Devices [ichroma Reader]

08806133010099FPRR001
08806133032008FPRR001

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