Duns Number:089855696
Device Description: Software for installing OncoMate MSI Dx Analysis System assay method on the 3500Dx Genetic Software for installing OncoMate MSI Dx Analysis System assay method on the 3500Dx Genetic Analyzer
Catalog Number
MD4150
Brand Name
OncoMate MSI Dx Assay Installer
Version/Model Number
MD4150
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200129
Product Code
PZJ
Product Code Name
Lynch Syndrome Test System
Public Device Record Key
5c4b2d07-91a9-4338-9d0e-957a796475bb
Public Version Date
October 18, 2021
Public Version Number
1
DI Record Publish Date
October 08, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |