FDA.reportPublic FDA data

AccuDiag™ Free Estriol ELISA

Primary DI
00850082766017
Brand
AccuDiag™ Free Estriol ELISA
Company
Diagnostic Automation, Inc.
Model
DACD3171-15
Catalog number
3171-15
Device description
AccuDiag™ Free Estriol ELISA A 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 an enzyme immunoassay (EIA) method.
Published
2026-01-27
Public version status
New
Distribution status
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
00850082766017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850082766017008500827660178500827660170850082766017

GMDN Terms#

Term, Definition table
TermDefinition
Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method. It is typically measured in maternal blood, urine or saliva as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
8185913030onestep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
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
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24
00850082766000QMedix™DACD113030-1-19113030-1-192025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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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