FDA.reportPublic FDA data

PROFESSIONAL SINGLE SLIDE KIT

Primary DI
B224SB211
Brand
PROFESSIONAL SINGLE SLIDE KIT
Company
CENOGENICS CORPORATION
Model
SB-21
Catalog number
SB-21
Device description
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
Published
2021-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHEReagent, Occult Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K761232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K761232000QUICK CULT SLIDE TEST FECAL OCCULT BLOODLaboratory Diagnostics Co., Inc.1976-12-21KHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B224SB211PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, chromogenic, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period relative to standard laboratory testing procedures, using a chromogenic method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(732) 536-6457info@cenogenics.net

Regulatory Flags#

DUNS number
068288943
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B224SB191TRI-SLIDE PATIENT ENVELOPE KITSB-19SB-192021-05-27
B224SB201TRI-SLIDE STOOL BLOOD TESTSB-20SB-202021-05-27
B224R201RF LATEX Test KitR-20R-202021-05-27
B224V611VDRL CONTROL SERUM KITV-612021-05-27
B224V551VDRL Antigen KitV-55V-552016-10-17

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Primary DI, Brand, Company table
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