FDA.reportPublic FDA data

Ultrasensitive Estradiol ELISA

Primary DI
B24220EDLHUUE010
Brand
Ultrasensitive Estradiol ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
20-EDLHUU-E01
Catalog number
11-ESTHU-E01
Device description
The Ultrasensitive Estradiol ELISA is an enzyme immunoassay for the quantitative measurement of estradiol in serum or plasma (EDTA, heparin, or citrate plasma). For In Vitro Diagnostic Use.
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHPRadioimmunoassay, Estradiol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHPRadioimmunoassay, EstradiolClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24220EDLHUUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B24280LACHUFC9000ALPCO Lactoferrin CLIA Kit80-LACHU-FC90080-LACHU-FC9002026-03-31
B24230PANHUE010Pancreatic Elastase ELISA30-PANHU-E0130-PANHU-E012020-07-17
B24280EZDEV21000Unfilled Easy 2 Stool Extraction Device80-EXDEV2-10080-EXDEV2-1002026-02-02
B24280EZEX21000Easy 2 Stool Extraction Device80-EZEX2-10080-EZEX2-1002025-10-30
B24280CALPHUCH500ALPCO Calprotectin Chemiluminescence ELISA80-CALPHU-CH5080-CALPHU-CH502019-11-04
B24224MABHUE010Microalbumin ELISA24-MABHU-E0124-MABHU-E012018-01-16
B24280LACHUFCSET0Lactoferrin CLIA Re-Calibrator and Control Set80-LACHU-FCSET2025-06-06
B24280PANHUFCSET0Pancreatic Elastase CLIA Re-Calibrator and Control Set80-PANHU-FCSET2025-06-06
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)25-TT4HU-E0125-TT4HU-E012017-08-03
B24211PREHUE010Pregnenolone ELISA11-PREHU-E0111-PREHU-E012020-09-25
B24280PANHUCH500Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH5080-PANHU-CH502022-09-09
B24280LACHUFC1000ALPCO Lactoferrin CLIA Kit80-LACHU-FC10080-LACHU-FC1002025-03-03
B24211HGHHUE010Human Growth Hormone ELISA11-HGHHU-E0111-HGHHU-E012025-01-20
B24280PANHUFC1000ALPCO Pancreatic Elastase CLIA80-PANHU-FC10080-PANHU-FC1002024-07-25
B24280PANHUCH010Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH0180-PANHU-CH012022-09-09
B24211GLUHUE010Glucagon ELISA11-GLUHU-E0111-GLUHU-E012024-10-23
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISA20-TT3HU-E0120-TT3HU-E012024-07-22
B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT20080-CALPHU-IT2002023-08-18
B24280CALPHUITCAL0Calprotectin Immunoturbidimetric Assay - Calibrators80-CALPHU-ITCAL80-CALPHU-ITCAL2023-08-18
B24280CALPHUITCON0ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-ITCON80-CALPHU-ITCON2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336218389Elecsys Estradiol IIIRoche Diagnostics GmbHCHP2026-06-01
00850054026682AccuDiag™ Estradiol ELISA Diagnostic Automation, Inc.CHP2026-01-27
07613336232125Ionify Steroids 1Roche Diagnostics GmbHCHP2025-12-11
14560189216621CL AIA-PACK hs-E2 TEST CUPTOSOH CORPORATIONCHP2025-09-01
24560189216628CL AIA-PACK hs-E2 TEST CUPTOSOH CORPORATIONCHP2025-09-01
04048474046649Estradiol (serum) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2024-11-21
0404932503053417beta-Estradiol Saliva Luminescence ImmunoassayIBL International GmbHCHP2023-09-29
0404932503054117beta-Estradiol Saliva Luminescence ImmunoassayIBL International GmbHCHP2023-09-29
00859410006245SalimetricsSALIMETRICS, LLCCHP2023-09-26
00859410006252SalimetricsSALIMETRICS, LLCCHP2023-09-26
04048474041880Salivary Estradiol ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474053494EstradiolDRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474061451Salivary Estradiol HS ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474043990Estradiol Sensitive ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-08-31
04048474026931Estradiol ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-08-29
00840239041883Salivary Estradiol ELISA DRG International IncCHP2023-08-26
00840239053497EstradiolDRG International IncCHP2023-08-26
00840239061454Salivary Estradiol HS ELISADRG International IncCHP2023-08-26
00840239043993Estradiol Sensitive ELISADRG International IncCHP2023-08-25
00840239026934Estradiol ELISADRG International IncCHP2023-08-23
00840239046642Estradiol (serum)DRG International IncCHP2023-08-22
00817830023037MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023044MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023051MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023068MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
15099590211523Ultra-sensitive Estradiol RIAIMMUNOTECH s.r.o.CHP2023-07-06
15099590699383Access Sensitive EstradiolBeckman Coulter, Inc.CHP2023-06-26
00894175000787AccuDiag ™Diagnostic Automation, Inc.CHP2023-06-14
00850039602740PantexPantexCHP2023-03-17
0404932503055817beta-Estradiol Saliva ELISAIBL International GmbHCHP2023-03-09