Duns Number:400686169
Device Description: The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode re The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch-screen that communicates with the Idylla™ Instruments. Idylla™ Console and up to eight Idylla™ Instruments constitute the Idylla™ System.
Catalog Number
P1010
Brand Name
Idylla™ System
Version/Model Number
Idylla™ Console
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OOI
Product Code Name
Real Time Nucleic Acid Amplification System
Public Device Record Key
782ca70b-751e-4bb4-8f39-64c4a1e447ac
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
August 21, 2017
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. | 2 |