FDA.reportPublic FDA data

AutoDELFIA hAFP kit

Primary DI
06438147321322
Brand
AutoDELFIA hAFP kit
Company
Wallac Oy
Model
B079-212
Catalog number
B079-212
Device description
Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hAFP)
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOKKit, Test, Alpha-Fetoprotein For Neural Tube DefectsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970037000
P970037009
P970037010
P970037011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970037000AUTODELFIA HAFP TEST KITRevvity, Inc.1998-03-31LOK
P970037009AUTODELFIA HAFP TEST KITRevvity, Inc.1998-03-31LOK
P970037010AUTODELFIA HAFP TEST KITRevvity, Inc.1998-03-31LOK
P970037011AUTODELFIA HAFP TEST KITRevvity, Inc.1998-03-31LOK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147321322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147321322064381473213226438147321322

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438147371815Qsight 210 MD Screening System2040-00102040-00102023-03-29
06438147411672NeoLSD MSMS kit3093-004U3093-004U2025-08-15
06438147179596AutoDELFIA Neonatal hTSH kitB032-02CB032-02C2016-02-02
06438147179602AutoDELFIA Neonatal Thyroxine (T4) kitB065-01CB065-01C2016-02-02
06438147292479AutoDELFIA Neonatal 17α-OH-progesterone kitB024-01CB024-01C2018-11-16
06438147344406AutoDELFIA Inhibin A kit Level Calibrators B064-112-P2B064-112-P22018-11-21
06438147344420AutoDELFIA Inhibin A kit B064-112B064-1122017-10-10
06438147355037AutoDELFIA Unconjugated Estriol (uE3) kitB095-112B095-1122018-11-16
06438147377732Eonis SCID-SMA kit3241-001U3241-001U2022-11-30
06438147377756Eonis SCID-SMA kit3242-001U3242-001U2022-11-30
06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
06438147333219VICTOR EnLite1420-02301420-02302019-03-19
06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
06438147009343AutoDELFIA hCG kitB007-112B007-1122016-02-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590744403Access AFPBeckman Coulter, Inc.LOK2025-11-10
00630414293561Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2020-05-31
00630414294117Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2020-05-31
00380740130794AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130800AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130817AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130824AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00630414238791Atellica IM AFPSiemens Healthcare Diagnostics Inc.LOK2018-11-14
00630414238807Atellica IM AFPSiemens Healthcare Diagnostics Inc.LOK2018-11-14
00630414597720Atellica IM AFP MCMSiemens Healthcare Diagnostics Inc.LOK2018-11-14
00630414598369Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2017-12-27
00630414598376Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2017-12-27
00630414022963ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2016-07-12
00380740112400ARCHITECTAbbott Ireland DiagnosticsLOK2014-12-19
00380740081287ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
00380740081294ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
00380740081317ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
06438147321315AutoDELFIA hAFP KitWallac OyLOK2014-09-24
00630414124797ADVIA Centaur® Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414124940ADVIA Centaur® Systems, ACS:180® Systems Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCMSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414177328ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414177335ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414953519IMMULITE®/IMMULITE®1000 Systems AF AFP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414961033IMMULITE® 2000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414961040IMMULITE® 2000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414963594IMMULITE®/IMMULITE®1000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
H628332111Access AFPBeckman Coulter, Inc.LOK2014-09-16
H628332161Access AFP Sample DiluentBeckman Coulter, Inc.LOK2014-09-16