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

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry (NQL) (2) Alpha-D-Galactosidase A (Gla) Newborn Screening Test System (PQW) (1) Apparatus, Electrophoresis, For Clinical Use (JJN) (1) Clinical Sample Concentrator (JJH) (1) Enzymatic Methods, Galactose (JIA) (1) Muscular Dystrophy Newborn Screening Test (QJE) (1)

Premarket Exempt

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NeoLSD MSMS kit - 06438147356218 Catalog Number : 3093-001U

Device Description : For the quantitative measurement of the activity of certain lysosomal enzymes in For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots.Note: Kit contains multiple packages.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : PQW

Prescription Use : Yes

Device Count : 1

chemagic 360-D - 06438147356706 Catalog Number : 2024-0010

Device Description : The chemagic 360-D is an automated laboratory instrument used in preanalytical p The chemagic 360-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : Yes

Device Count : 1

NeoBase 2 Non-derivatized MSMS kit - 06438147356812 Catalog Number : 3044-001U

Device Description : NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluati NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations from newborn heel prick blood samples dried on filter paper.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NQL

Prescription Use : Yes

Device Count : 1

NeoBase 2 Succinylacetone Assay Solution - 06438147356829 Catalog Number : 3046-0010

Device Description : NeoBase™ 2 Succinylacetone Assay Solution is intended for in vitro diagnostic us NeoBase™ 2 Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit and the NeoBase2 Non-derivatized Assay Solutions to extract succinylacetone from blood samples dried on filter paper.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NQL

Prescription Use : Yes

Device Count : 1

GSP Neonatal Creatine Kinase -MM kit - 06438147362615 Catalog Number : 3311-001U

Device Description : For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood.Note: Kit contains multiple packages.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : QJE

Prescription Use : Yes

Device Count : 1

GSP Neonatal Total Galactose kit - 06438147367917 Catalog Number : 3309-002U

Device Description : For the quantitative determination of total galactose concentration in dried blo For the quantitative determination of total galactose concentration in dried blood.Note: Kit contains multiple packages.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JIA

Prescription Use : Yes

Device Count : 1

Migele Gel Electrophoresis Unit - 06438147368907 Catalog Number : 2118-0010

Device Description : Migele™ Gel Electrophoresis Unit (GEU) is intended for professional use together Migele™ Gel Electrophoresis Unit (GEU) is intended for professional use together with power supply, water bath and isoelectric focusing (IEF) gels. GEU is used for the isoelectric point-based separation of sample compounds, e.g. hemoglobin variants found in blood samples, by applying a given amount of electrical current to the immobilized pH-gradient containing agarose.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : JJN

Prescription Use : Yes

Device Count : 1

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