Duns Number:052934841
Device Description: Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory work Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.
Catalog Number
-
Brand Name
Sunquest Mitogen LIMS
Version/Model Number
4.1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JQP
Product Code Name
Calculator/Data Processing Module, For Clinical Use
Public Device Record Key
b15c4092-f429-483f-8077-09b5f0322572
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
August 05, 2022
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |