Duns Number:068288943
Device Description: Cenogenics Corporation's PROFESSIONAL SINGLE SLIDE KIT is a two test guaiac slide procedur 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
Catalog Number
SB-21
Brand Name
PROFESSIONAL SINGLE SLIDE KIT
Version/Model Number
SB-21
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K761232
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
5e9ec2d8-8097-47ae-b789-221e262bcdaf
Public Version Date
June 04, 2021
Public Version Number
1
DI Record Publish Date
May 27, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |