Wallac Oy

Address:MUSTIONKATU 6,TURKU Varsinais-Suomi,FI

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects (LOK) (2) Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (KLI) (1) Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase (KQP) (1) Fluorometer, For Clinical Use (KHO) (1) N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin (JNO) (1) Radioimmunoassay, 17-Hydroxyprogesterone (JLX) (1) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (1) Calculator/Data Processing Module, For Clinical Use (JQP) (1) System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry (NQL) (1)

Premarket Exempt

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Genetic Screening Processor - 06438147311040 Catalog Number : 2021-0010

Device Description : The GSP® instrument is a fully automated, high throughput batch analyzer for tim The GSP® instrument is a fully automated, high throughput batch analyzer for time-resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : KHO

Prescription Use : No

Device Count : 1

NeoBase Non-derivatized MSMS kit - 06438147311859 Catalog Number : 3040-001U

Device Description : For the quantitative determination of amino acid, acylcarnitine and free carniti For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NQL

Prescription Use : No

Device Count : 1

GSP Neonatal hTSH kit - 06438147312009 Catalog Number : 3301-001U

Device Description : For the quantitative determination of human thyrotropin (thyroid stimulating hor For the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : JLW

Prescription Use : No

Device Count : 1

GSP Neonatal Thyroxine (T4) kit - 06438147312139 Catalog Number : 3302-001U

Device Description : For the quantitative determination of thyroxine (T4) in dried blood.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : KLI

Prescription Use : No

Device Count : 1

GSP Neonatal IRT kit - 06438147320523 Catalog Number : 3306-001U

Device Description : For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JNO

Prescription Use : No

Device Count : 1

Screening Center - 06438147320905 Catalog Number : 5002-0500

Device Description : Specimen Gate® Screening Center™ is intended to be used for data management of n Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : Yes

Device Count : 1

GSP Neonatal 17α-OH-progesterone kit - 06438147321209 Catalog Number : 3305-001U

Device Description : Time-resolved fluoroimmunoassay for the quantitative determination of 17a-OH-pro Time-resolved fluoroimmunoassay for the quantitative determination of 17a-OH-progesterone (17-OHP) in dried blood.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JLX

Prescription Use : Yes

Device Count : 1

AutoDELFIA hAFP Kit - 06438147321315 Catalog Number : B079-201

Device Description : Time-resolved fluoroimmunoassay for the quantitative determination of human alph Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP)

Device Class : 3

Duns Number: 540156544

Premarket Exempt : No

Product Code : LOK

Prescription Use : No

Device Count : 1

AutoDELFIA hAFP kit - 06438147321322 Catalog Number : B079-212

Device Class : 3

Duns Number: 540156544

Premarket Exempt : No

Product Code : LOK

Prescription Use : No

Device Count : 1

GSP Neonatal GALT kit - 06438147321704 Catalog Number : 3303-001U

Device Description : For the quantitative determination of GALT (galactose-1-phosphate uridyl transfe For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) activity in dried blood. Note: Kit contains multiple packages.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : KQP

Prescription Use : No

Device Count : 1

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