Duns Number:227530649
Device Description: The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemi The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software.
Catalog Number
RX4041
Brand Name
RX daytona plus
Version/Model Number
RX4041
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
K131554
Product Code
JJE
Product Code Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Public Device Record Key
2f64c290-aa9a-44ea-8ea1-bd1b3aa51fdc
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
June 07, 2018
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |