FDA.reportPublic FDA data

AutoDELFIA Neonatal hTSH kit

Primary DI
06438147179596
Brand
AutoDELFIA Neonatal hTSH kit
Company
Wallac Oy
Model
B032-02C
Catalog number
B032-02C
Device description
Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.
Published
2016-02-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JLWRadioimmunoassay, Thyroid-Stimulating Hormone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLWRadioimmunoassay, Thyroid-Stimulating HormoneClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147179596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147179596064381471795966438147179596

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal thyroid stimulating hormone (neonatal TSH) 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
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
06438147064564DELFIA Platewash1296-0261296-0262021-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850049545044AccuDiag™Diagnostic Automation, Inc.JLW2024-11-14
00630414624488ADVIA Centaur TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624501ADVIA Centaur TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624518Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624525Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624532Atellica IM TSH3ULII MCM setSiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624693Atellica IM TSH3-Ultra IISiemens Healthcare Diagnostics Inc.JLW2024-05-22
00630414624709ADVIA Centaur TSH3ULII MCM SETSiemens Healthcare Diagnostics Inc.JLW2024-05-22
00850054026262AccuDiag ™Diagnostic Automation, Inc.JLW2024-03-27
00850054026538QMedix™Diagnostic Automation, Inc.JLW2024-03-06
00850054026439QMedix™Diagnostic Automation, Inc.JLW2024-01-31
04048474052664Total Triiodothyronine (tT3) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-09-01
04048474052831Thyrotropin (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-09-01
04048474041118Thyrotropin (TSH) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-31
04048474017823Thyroid Stimulating Hormone (TSH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
04048474017908TSH (ultrasensitive) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLW2023-08-26
00840239052834Thyrotropin (TSH) ELISADRG International IncJLW2023-08-25
15099590744373Access TSH (3rd IS)Beckman Coulter, Inc.JLW2022-12-31
07613336193693Elecsys TSHRoche Diagnostics GmbHJLW2022-11-18
06947145500016MAGLUMI 2000 TSHShenzhen New Industries Biomedical Engineering Co., Ltd.JLW2022-08-02
06947145500023MAGLUMI 2000 TSHShenzhen New Industries Biomedical Engineering Co., Ltd.JLW2022-08-02
00725609000618SPOTCHECKASTORIA-PACIFIC, INC.JLW2020-12-17
00630414293875Atellica IM TSH3-ULSiemens Healthcare Diagnostics Inc.JLW2020-12-12
00842768032417Dimension® EXL™/ Dimension Vista® MULTI 2 SDILSiemens Healthcare Diagnostics Inc.JLW2020-09-24
00630414293806Atellica IM TSH3-ULSiemens Healthcare Diagnostics Inc.JLW2020-05-31
00722066001950Rapid ResponseBTNX IncJLW2019-10-16
00850392007015BioCheck TSH EIA Test KitBIOCHECK, INC.JLW2019-10-08
00850392007039BioCheck U-TSH EIA Test KitBIOCHECK, INC.JLW2019-10-08
00840239014832Neonatal TSH ELISADRG International IncJLW2019-06-10
00840239041111Thyrotropin (TSH) ELISADRG International IncJLW2019-06-10