FDA.reportPublic FDA data

AutoDELFIA Neonatal 17α-OH-progesterone kit

Primary DI
06438147292479
Brand
AutoDELFIA Neonatal 17α-OH-progesterone kit
Company
Wallac Oy
Model
B024-01C
Catalog number
B024-01C
Device description
For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.
Published
2018-11-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JLXRadioimmunoassay, 17-Hydroxyprogesterone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081922000AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OY2009-04-16JLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147292479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147292479064381472924796438147292479

GMDN Terms#

Term, Definition table
TermDefinition
17-Hydroxyprogesterone IVD, kit, fluorescent immunoassayA 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 a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
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06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
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06438147391998DBS Controls LysoPC3413-00103413-00102024-01-08
06438147392339LysoPC IS4417-00104417-00102024-01-08
06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11
06438147356218NeoLSD MSMS kit3093-001U3093-001U2018-11-28
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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
0404932503362717-OH-Progesterone ELISAIBL International GmbHJLX2022-12-28
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