Duns Number:301237509
Device Description: The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includes Magella The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.It is intended to be integrated in robotic solutions.
Catalog Number
30087509
Brand Name
Infinite F50 ROBOTIC
Version/Model Number
30087509 01
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
-
Product Code
JJQ
Product Code Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Public Device Record Key
daa213a4-68a4-4be2-bcab-2bdfe01f382b
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
July 12, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |