Duns Number:540156544
Device Description: For the quantitative determination of europium (Eu³⁺) and samarium (Sm³⁺) in dissociation- For the quantitative determination of europium (Eu³⁺) and samarium (Sm³⁺) in dissociation-enhanced time-resolved fluoroimmunoassays.
Catalog Number
1244-105
Brand Name
DELFIA Enhancement Solution
Version/Model Number
1244-105
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
30c629ae-b4fb-4be6-8978-c1d4f6819315
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 16, 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 | 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 |