FDA.reportPublic FDA data

AutoDELFIA Unconjugated Estriol (uE3) kit

Primary DI
06438147355037
Brand
AutoDELFIA Unconjugated Estriol (uE3) kit
Company
Wallac Oy
Model
B095-112
Catalog number
B095-112
Device description
Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).
Published
2018-11-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CGIRadioimmunoassay, Estriol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGIRadioimmunoassay, EstriolClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147355037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147355037064381473550376438147355037

GMDN Terms#

Term, Definition table
TermDefinition
Free estriol (oestriol) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using a fluorescent immunoassay method. It is typically measured in maternal blood or urine as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.

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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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06438147292479AutoDELFIA Neonatal 17α-OH-progesterone kitB024-01CB024-01C2018-11-16
06438147344406AutoDELFIA Inhibin A kit Level Calibrators B064-112-P2B064-112-P22018-11-21
06438147344420AutoDELFIA Inhibin A kit B064-112B064-1122017-10-10
06438147377732Eonis SCID-SMA kit3241-001U3241-001U2022-11-30
06438147377756Eonis SCID-SMA kit3242-001U3242-001U2022-11-30
06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
06438147333219VICTOR EnLite1420-02301420-02302019-03-19
06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
06438147009343AutoDELFIA hCG kitB007-112B007-1122016-02-11
06438147391998DBS Controls LysoPC3413-00103413-00102024-01-08
06438147392339LysoPC IS4417-00104417-00102024-01-08
06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11
06438147356218NeoLSD MSMS kit3093-001U3093-001U2018-11-28
06438147064564DELFIA Platewash1296-0261296-0262021-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850082766017AccuDiag™ Free Estriol ELISA Diagnostic Automation, Inc.CGI2026-01-27
04048474016123Free Estriol ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGI2024-11-22
04048474053517Free EstriolDRG Instruments Gesellschaft mit beschränkter HaftungCGI2023-09-01
00840239053510Free EstriolDRG International IncCGI2023-08-26
00840239016126Free Estriol ELISADRG International IncCGI2023-08-23
04049016147602Free Estriol ELISAEUROIMMUN Medizinische Labordiagnostika AGCGI2022-12-08
B261CANE6400DBC Free Estriol ELISADiagnostics Biochem Canada IncCGI2022-11-15
00404847416121Free Estriol ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGI2021-06-07
B24220FE3HUE010Free Estriol ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CGI2020-09-25
00630414984452IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated EstriolSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGI2020-09-24
00630414997162IMMULITE® 2000 Systems UE3 Unconjugated EstriolSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGI2020-09-24
00816870021393uE3 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CGI2019-02-11
00816870021409uE3 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CGI2019-02-11
00816870022833uE3 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CGI2019-02-11
00816870022840uE3 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CGI2019-02-11
06438147355013AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2018-11-16
06438147119332AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2016-06-01
06438147119745AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2016-06-01