FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol

Primary DI
00630414984452
Brand
IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381168
Catalog number
LKUE31
Device description
Estriol unconjugated - IMMULITE - RGT - 100 Tests
Published
2020-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00630414984452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414984452006304149844526304149844520630414984452

GMDN Terms#

Term, Definition table
TermDefinition
Free estriol (oestriol) IVD, kit, chemiluminescent 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 chemiluminescent 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

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
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
06438147355037AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2018-11-16
06438147119332AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2016-06-01
06438147119745AutoDELFIA Unconjugated Estriol (uE3) kitWallac OyCGI2016-06-01