FDA.reportPublic FDA data

Progesterone ELISA

Primary DI
B24211PROHUE010
Brand
Progesterone ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
11-PROHU-E01
Catalog number
11-PROHU-E01
Device description
Intended for the direct quantitative determination of Progesterone by enzyme immunoassay using 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
JLSRadioimmunoassay, Progesterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLSRadioimmunoassay, ProgesteroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24211PROHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Progesterone 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 progesterone 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
00894175000800AccuDiag™ Progesterone ELISADiagnostic Automation, Inc.JLS2026-01-30
14562185399667CL AIA-PACK Progesterone TEST CUPTOSOH CORPORATIONJLS2025-09-01
24562185399664CL AIA-PACK Progesterone TEST CUPTOSOH CORPORATIONJLS2025-09-01
10758750035366VITROSORTHO CLINICAL DIAGNOSTICSJLS2025-05-20
20758750035363VITROSORTHO CLINICAL DIAGNOSTICSJLS2025-05-20
04048474015614Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2024-11-22
04048474046632Progesterone (serum) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2024-11-21
07613336218419Elecsys Progesterone IIIRoche Diagnostics GmbHJLS2024-05-30
15099590752682Access Progesterone IIBeckman Coulter, Inc.JLS2024-03-01
15099590752705Access Progesterone II Sample DiluentBeckman Coulter, Inc.JLS2024-03-01
04048474029314Salivary Progesterone ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
04048474053685Progesterone DRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
04048474059113Salivary Progesterone HS ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
00840239029317Salivary Progesterone ELISA DRG International IncJLS2023-08-26
00840239053688Progesterone DRG International IncJLS2023-08-26
00840239059116Salivary Progesterone HS ELISADRG International IncJLS2023-08-26
00840239015617Progesterone ELISADRG International IncJLS2023-08-23
00840239046635Progesterone (serum) DRG International IncJLS2023-08-22
00817830023167MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023174MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023181MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023198MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00850039602733PantexPantexJLS2023-03-17
00850039602375PantexPantexJLS2023-02-17
B261CANP3050DBC Progesterone ELISADiagnostics Biochem Canada IncJLS2022-11-15
06925912718918iFlash-ProgesteroneShenzhen YHLO Biotech Co., Ltd.JLS2022-10-26
03770024321609PROGEST-USCISBIO BIOASSAYSJLS2021-12-07
15099590231354ACCESS PROGESTERONE CALIBRATOR S0Beckman Coulter, Inc.JLS2021-09-03
15099590231378Access ProgesteroneBeckman Coulter, Inc.JLS2021-09-03
00404847415612Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2021-06-07