TRI-SLIDE STOOL BLOOD TEST SB-20

GUDID B224SB201

Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding. The Kit Contains: 100 three-section slides with controls. Each section contains two test sites (6 tests/slide) and a positive and negative control set. 300 applicators 6 X 10ml developing solution Product Instructions

CENOGENICS CORPORATION

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Primary Device IDB224SB201
NIH Device Record Key35022ff1-c732-4dd1-8034-5c51da4d5291
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRI-SLIDE STOOL BLOOD TEST
Version Model NumberSB-20
Catalog NumberSB-20
Company DUNS068288943
Company NameCENOGENICS CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net
Phone(732) 536-6457
Emailinfo@cenogenics.net

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB224SB201 [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 Date2021-06-04
Device Publish Date2021-05-27

Devices Manufactured by CENOGENICS CORPORATION

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B224SB201 - TRI-SLIDE STOOL BLOOD TEST2021-06-04Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding. The Kit Contains: 100 three-section slides with controls. Each section contains two test sites (6 tests/slide) and a positive and negative control set. 300 applicators 6 X 10ml developing solution Product Instructions
B224SB201 - TRI-SLIDE STOOL BLOOD TEST2021-06-04 Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide procedure to effectively screen for intermittent
B224SB211 - PROFESSIONAL SINGLE SLIDE KIT2021-06-04 Cenogenics Corporation's PROFESSIONAL SINGLE SLIDE KIT is a two test guaiac slide procedure to screen for gastrointestinal bleed
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