DELFIA Enhancement Solution - For the quantitative determination of europium - Wallac Oy

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.

Want to know more about this Product? Request more information now!


More Product Details

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

Product Characteristics

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 Details

Product Code

PPM

Product Code Name

General Purpose Reagent

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WALLAC OY" Characteristics
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