Duns Number:298203498
Device Description: The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobial susceptibility testing and identification of bacterial pathogens; designed to accommodate up to 100 Sensititre™ microtitre plates within a single instrument.
Catalog Number
-
Brand Name
Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST
Version/Model Number
V4000
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
K191914,K191918
Product Code
LRG
Product Code Name
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Public Device Record Key
2b9034ef-7f11-4a81-9834-27b751e85416
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
January 17, 2020
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. | 1 |