Duns Number:540156544
Device Description: Used with 1235-501 AutoDELFIA® Plate Processor System or 1235-514 Fully Automatic DELFIA® Used with 1235-501 AutoDELFIA® Plate Processor System or 1235-514 Fully Automatic DELFIA® System
Catalog Number
1235-001
Brand Name
AutoDELFIA Plate Processor
Version/Model Number
1235-001
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
KHO
Product Code Name
Fluorometer, For Clinical Use
Public Device Record Key
7f491669-fad1-492d-838e-3ecfbfef61cb
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2014
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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |