FDA.reportPublic FDA data

Estrone ELISA

Primary DI
B24211ESRHUE010
Brand
Estrone ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
11-ESRHU-E01
Catalog number
11-ESRHU-E01
Device description
Intended for the direct quantitative determination of Estrone by an enzyme immunoassay in human serum. For In Vitro Diagnostic Use.
Published
2020-09-25
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
CGFRadioimmunoassay, Estrone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGFRadioimmunoassay, EstroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24211ESRHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Estrone (oestrone) 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 estrone (oestrone) 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
04048474040791Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474041743Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474046540Estrone SerumDRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-26
00840239041746Estrone ELISADRG International IncCGF2023-08-25
15099590211547Estrone-sulfate RIAIMMUNOTECH s.r.o.CGF2023-07-06
15099590211615Estrone RIAIMMUNOTECH s.r.o.CGF2023-07-06
B652IB59105Estrone ELISAIBL AmericaCGF2023-06-08
04049016148388Estrone ELISAEUROIMMUN Medizinische Labordiagnostika AGCGF2022-12-08
B261CANE4200DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
B261CANE4208PK0DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
00404847441741Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2021-06-07
00840239040794Estrone ELISADRG International IncCGF2021-06-07
00840239046543Estrone Serum ELISADRG International IncCGF2021-06-07
05400569000674Estrone-RIA-CTDiasource Immunoassays S.A. SACGF2020-09-16
05400569005167Estrone ELISADiasource Immunoassays S.A. SACGF2020-01-09