Duns Number:605151018
Device Description: Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde conce Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Minimum Effective Concentration (MEC) of 1.5% for CIDEX® or MetriCide® reusable glutaraldehyde high-level disinfectants.
Catalog Number
5136A
Brand Name
Serim® DISINTEK™ GTA 1.5% Test Strips
Version/Model Number
5136A
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
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
f80c25b2-63c6-407a-ad56-478b47e43b6a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 08, 2016
Package DI Number
M1745136A2
Quantity per Package
2
Contains DI Package
M1745136A1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit