PROFESSIONAL SINGLE SLIDE KIT SB-21

GUDID B224SB211

Cenogenics Corporation's PROFESSIONAL SINGLE SLIDE KIT is a two test guaiac slide procedure to screen for gastrointestinal bleeding. The Kit Contains: 100 single slides. Each slide has two test areas and a positive and negative control set. 100 applicators 2 X 10ml developing solution Product Instructions

CENOGENICS CORPORATION

Faecal occult blood IVD, kit, chromogenic, rapid
Primary Device IDB224SB211
NIH Device Record Key5e9ec2d8-8097-47ae-b789-221e262bcdaf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFESSIONAL SINGLE SLIDE KIT
Version Model NumberSB-21
Catalog NumberSB-21
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 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(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
HIBCCB224SB211 [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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B224SB191 - TRI-SLIDE PATIENT ENVELOPE KIT2021-06-04 Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedure to effectively screen for intermitt
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 KIT2021-06-04Cenogenics Corporation's PROFESSIONAL SINGLE SLIDE KIT is a two test guaiac slide procedure to screen for gastrointestinal bleeding. The Kit Contains: 100 single slides. Each slide has two test areas and a positive and negative control set. 100 applicators 2 X 10ml developing solution Product Instructions
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
B224V611 - VDRL CONTROL SERUM KIT2021-06-04 Cenogenics Corporation's VDRL CONTROL SERUM KIT is a set of syphilitic and non-syphilitic human sera for use with the VDRL slide
B224V551 - VDRL Antigen Kit2018-03-29 VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced

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