EZ Detect Colon Disease Test

GUDID 08305900100013

Home Test For Hidden Blood in The Stool

BIOMERICA, INC.

Faecal occult blood IVD, kit, chromogenic, rapid
Primary Device ID08305900100013
NIH Device Record Keyb24c2937-47fb-4044-8d20-99f35387aa9f
Commercial Distribution Discontinuation2020-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEZ Detect Colon Disease Test
Version Model Number1000-1
Company DUNS067647321
Company NameBIOMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108305900100013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHEReagent, Occult Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-02
Device Publish Date2016-12-08

On-Brand Devices [EZ Detect Colon Disease Test]

00083059100013Home Test For Hidden Blood in The Stool
08305900100013Home Test For Hidden Blood in The Stool

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