Duns Number:540156544
Device Description: For the quantitative determination of europium (Eu³⁺) in dissociation-enhanced time-resolv For the quantitative determination of europium (Eu³⁺) in dissociation-enhanced time-resolved fluoroimmunoassays.
Catalog Number
3304-0010
Brand Name
DELFIA Inducer
Version/Model Number
3304-0010
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
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
6ddf83d8-53df-4826-aef0-4a739112df28
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 28, 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 |
|---|---|---|
| 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 |