Duns Number:068288943
Device Description: Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedu Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding.The Kit Contains: 50 patient envelope kits. Each Patient Kit contains one Tri-Slide with controls and 3 applicator sticks. The envelopes are printed with easy to understand patient instructions. 3 X 10ml developing solution Product Instructions
Catalog Number
SB-19
Brand Name
TRI-SLIDE PATIENT ENVELOPE KIT
Version/Model Number
SB-19
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
5fa17a9e-6b49-4f7f-ad10-5f3088f87e23
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 |