Reese's ColoTest

GUDID 10023513132157

REESE PHARMACEUTICAL COMPANY

Faecal occult blood IVD, kit, rapid ICT, clinical
Primary Device ID10023513132157
NIH Device Record Key667f0b20-13bd-4445-a095-6275c5dc8e1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameReese's ColoTest
Version Model Number05-7632RS-2
Company DUNS004172052
Company NameREESE PHARMACEUTICAL COMPANY
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 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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110023513132157 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-06
Device Publish Date2024-04-26