FDA.reportPublic FDA data

DELFIA Inducer

Primary DI
06438147299645
Brand
DELFIA Inducer
Company
Wallac Oy
Model
3304-0010
Catalog number
3304-0010
Device description
For the quantitative determination of europium (Eu³⁺) in dissociation-enhanced time-resolved fluoroimmunoassays.
Published
2017-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147299645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147299645064381472996456438147299645

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay dissociation-enhancement reagent IVDA substance or reactant intended to be used when performing a time-resolved fluorescent immunoassay on a clinical specimen to enhance and/or optimise the signal by dissociating the fluorescent label from antigen or antibody bound in the solid phase and inducing the formation of highly detectable chelates in solution.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06438147377732Eonis SCID-SMA kit3241-001U3241-001U2022-11-30
06438147377756Eonis SCID-SMA kit3242-001U3242-001U2022-11-30
06438147366804EVOYA Platform5021-10005021-10002022-11-29
06438147335008AutoDELFIA Automatic Immunoassay System1235-51101235-51102022-08-11
06438147335022AutoDELFIA Automatic Immunoassay System1235-5220 1235-52202022-08-11
06438147064564DELFIA Platewash1296-0261296-0262021-06-04
06438147362615GSP Neonatal Creatine Kinase -MM kit3311-001U3311-001U2021-06-04
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