DELFIA Enhancement Solution B118-100

GUDID 06438147009725

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 ID06438147009725
NIH Device Record Key07f84788-7acf-41b0-8b80-8b3a16548a67
Commercial Distribution StatusIn Commercial Distribution
Brand NameDELFIA Enhancement Solution
Version Model NumberB118-100
Catalog NumberB118-100
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
GS106438147009725 [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-

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.