Duns Number:540156544
Device Description: Used with 1235-5220 AutoDELFIA® System (SP and PP).
Catalog Number
1297-0110
Brand Name
AutoDELFIA Sample processor
Version/Model Number
1297-0110
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
1a408461-7998-45ee-a8e1-b947e6d6208a
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
July 01, 2016
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 |