FDA.reportPublic FDA data

17-OH-Progesterone ELISA

Primary DI
04049325033627
Brand
17-OH-Progesterone ELISA
Company
IBL International GmbH
Model
30223011
Catalog number
30223011
Device description
17-OH-Progesterone ELISA - 96 Determinations
Published
2022-12-28
Public version status
Update
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
JLXRadioimmunoassay, 17-Hydroxyprogesterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLXRadioimmunoassay, 17-HydroxyprogesteroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049325033627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049325033627040493250336274049325033627

GMDN Terms#

Term, Definition table
TermDefinition
17-Hydroxyprogesterone 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 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of congenital adrenal hyperplasia (CAH).

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
+49405328910IBL@Tecan.com

Regulatory Flags#

DUNS number
312694785
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
04049325034754DHEA ELISA30252873302528732025-04-30
0404932501235617beta-Estradiol Saliva Luminescence ImmunoassayRE62141RE621412020-12-29
0404932501236317beta-Estradiol Saliva Luminescence ImmunoassayRE62149RE621492020-12-29
04049325008304Active-B12 (Holotranscobalamin) ELISAAX53101AX531012016-09-24
0404932503053417beta-Estradiol Saliva Luminescence ImmunoassayRE62141RE621412023-09-29
0404932503054117beta-Estradiol Saliva Luminescence ImmunoassayRE62149RE621492023-09-29
0404932503055817beta-Estradiol Saliva ELISA30121045301210452023-03-09
04049325001787DHEA-S ELISARE52181RE521812020-12-29
04049325014879Unassayed Testosterone QC Material30108902301089022020-12-29
0404932501721417beta-Estradiol Saliva ELISA30121045301210452020-12-29
04049325003545Testosterone Luminescence ImmunoassayRE62031RE620312020-10-20
04049325006546Testosterone Luminescence ImmunoassayRE62039.RE62039.2020-10-20
04049325003606SaliCapsRE69991.RE69991.2020-12-29
04049325003613SaliCapsRE69995.RE69995.2020-12-29
04049325003521Progesterone Luminescence ImmunoassayRE62021RE620212020-12-29
04049325003538Progesterone Luminescence ImmunoassayRE62029RE620292020-12-29
04049325001404Acetylcholine Receptor Autoantibodies (ARAb) RRARE21021RE210212016-09-24
04049325001428Acetylcholine Receptor Autoantibodies (ARAb) RRARE21023RE210232016-09-24
04049325007727Cortisol Saliva Luminescence ImmunoassayRE62111RE621112016-09-24
04049325007734Cortisol Saliva Luminescence ImmunoassayRE62119RE621192016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B261CANP5400DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2026-04-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADiagnostic Automation, Inc.JLX2026-01-27
0404847401292717 OH-Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2024-11-18
00816870021164N-17-OHP AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JLX2024-09-13
00816870021171N-17-OHP AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JLX2024-09-13
00816870021188N-17-OHP AccuBind ELISA Test System - 480 WellsMONOBIND, INC.JLX2024-09-13
00816870021195N-17-OHP AccuBind ELISA Test System - 960 WellsMONOBIND, INC.JLX2024-09-13
00816870021201N-17-OHP AccuBind ELISA Test System - 1920 WellsMONOBIND, INC.JLX2024-09-13
04048474031409Salivary 17-OH Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-09-01
04048474053333Progesterone (17-a-OH Progesterone)DRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-09-01
00840239031402Salivary 17-OH Progesterone ELISADRG International IncJLX2023-08-26
00840239053336Progesterone (17-a-OH Progesterone)DRG International IncJLX2023-08-26
04048474014297Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-08-26
0084023901292017 OH Progesterone ELISADRG International IncJLX2023-08-23
00840239012937C-Peptide ELISADRG International IncJLX2023-08-23
00840239014290Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG International IncJLX2023-08-23
00840239046659Progesterone, 17-a-OHDRG International IncJLX2023-08-22
00817830023150MP Biomedicals LLCMp Biomedicals, LLCJLX2023-08-02
0404901613838917-OH Progesterone ELISAEUROIMMUN Medizinische Labordiagnostika AGJLX2022-12-08
B261CANP3200DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2022-11-15
B261CANP4000DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2022-11-15
06925912718048iFlash-17α-OH-PShenzhen YHLO Biotech Co., Ltd.JLX2022-10-26
0040484741292517 OH-Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847431407Salivary 17-OH Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847446654Progesterone, 17-a-OH ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847453331Progesterone (17-a-OH Progesterone)DRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00725609000625SPOTCHECKASTORIA-PACIFIC, INC.JLX2020-12-17
B2422017OHUE01017-alpha Hydroxy Progesterone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JLX2020-06-18
B2422017OHUE01SLV017-alpha Hydroxy Progesterone ELISA (Saliva)AMERICAN LABORATORY PRODUCTS COMPANY, LTD.JLX2020-06-18
0540056900047617OHP RIA CTDiasource Immunoassays S.A. SAJLX2020-01-15