DELFIA Enhancement Solution 1244-105

GUDID 06438147005260

For the quantitative determination of europium (Eu³⁺) and samarium (Sm³⁺) in dissociation-enhanced time-resolved fluoroimmunoassays.

Wallac Oy

Fluorescent immunoassay dissociation-enhancement reagent IVD
Primary Device ID06438147005260
NIH Device Record Key30c629ae-b4fb-4be6-8978-c1d4f6819315
Commercial Distribution StatusIn Commercial Distribution
Brand NameDELFIA Enhancement Solution
Version Model Number1244-105
Catalog Number1244-105
Company DUNS540156544
Company NameWallac Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147005260 [Primary]

FDA Product Code

PPMGeneral Purpose Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-17
Device Publish Date2018-11-16

On-Brand Devices [DELFIA Enhancement Solution]

06438147009725For the quantitative determination of europium (Eu³⁺) and samarium (Sm³⁺) in dissociation-
06438147005260For the quantitative determination of europium (Eu³⁺) and samarium (Sm³⁺) in dissociation-
06438147005253For the quantitative determination of europium (Eu³⁺) and samarium (Sm³⁺) in dissociation-

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