ColoScreen iFOBT Mailer

GUDID M52550631

HELENA LABORATORIES CORPORATION

Faecal occult blood IVD, kit, rapid colorimetric, clinical
Primary Device IDM52550631
NIH Device Record Keyd63a8829-b5ef-4e5e-ac1e-10138b6940d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameColoScreen iFOBT Mailer
Version Model Number5063
Company DUNS079396131
Company NameHELENA LABORATORIES CORPORATION
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM5250034640 [Unit of Use]
HIBCCM52550631 [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 Number3
Public Version Date2022-11-28
Device Publish Date2018-03-16

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M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit2023-09-18
M52510680010 - SPIFE Touch, CSA 2015 (120V)2023-09-11

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