Duns Number:830140377
Device Description: The iC-System is an in vitro diagnostic device designed to perform multiplex amplification The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
Catalog Number
-
Brand Name
iC-Processor
Version/Model Number
iCP-ADAAA0000
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
-
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
K163390
Product Code
NSU
Product Code Name
Instrumentation For Clinical Multiplex Test Systems
Public Device Record Key
c107f2e1-8d10-48ba-97ea-fdacaa054e71
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
July 10, 2019
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. | 4 |