Duns Number:605151018
Device Description: Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether th Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%.
Catalog Number
5121
Brand Name
Serim® DISINTEK™ OPA Test Strips
Version/Model Number
5121
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOJ
Product Code Name
Indicator, Physical/Chemical Sterilization Process
Public Device Record Key
c260f68e-2a71-4829-a04e-576ebb1abeaf
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 08, 2016
Package DI Number
M17451212
Quantity per Package
2
Contains DI Package
M17451211
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit