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

Abnormal Hemoglobin Quantitation (GKA) (2) General Purpose Reagent (PPM) (2) System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry (NQL) (2) System,Test,Biotinidase (NAK) (2) Enzymatic Methods, Galactose (JIA) (1) Radioimmunoassay, Total Thyroxine (CDX) (1)

Premarket Exempt

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AutoDELFIA Neonatal Thyroxine (T4) kit - 06438147179602 Catalog Number : B065-01C

Device Description : Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : CDX

Prescription Use : No

Device Count : 1

DELFIA Diluent 3 - 06438147244881 Catalog Number : 4021-0010

Device Description : For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

DELFIA Diluent 3 - 06438147244898 Catalog Number : 4022-0010

Device Description : For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

RESOLVE Systems Hb Elution Solution - 06438147246120 Catalog Number : 3024-0010

Device Description : For in vitro use with the RESOLVE Hemoglobin Kits for isoelectric focusing.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

RESOLVE Systems Hb Elution Solution - 06438147246137 Catalog Number : 3025-0010

Device Description : For in vitro use with the RESOLVE Hemoglobin Kits for isoelectric focusing.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : GKA

Prescription Use : Yes

Device Count : 1

Neonatal Total Galactose kit - 06438147275281 Catalog Number : 3029-0010

Device Description : For the quantitative determination of galactose and galactose-1-phosphate in dri

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JIA

Prescription Use : Yes

Device Count : 1

NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit - 06438147283835 Catalog Number : 3026-0030

Device Description : For the quantitative determination of amino acid, acylcarnitine and free carniti

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NQL

Prescription Use : No

Device Count : 1

NeoGram Derivatized Assay Solutions - 06438147283842 Catalog Number : 3030-0020

Device Description : The product is to be used together with the NeoGram Amino Acids and Acylcarnitin

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NQL

Prescription Use : No

Device Count : 1

Neonatal Biotinidase kit - 06438147291342 Catalog Number : 3018-0010

Device Description : For the semi-quantitative determination of biotinidase in dried blood. Note: Kit

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NAK

Prescription Use : No

Device Count : 1

Neonatal Biotinidase kit - 06438147291359 Catalog Number : 3018-001B

Device Description : For the semi-quantitative determination of biotinidase in dried blood. Note: Kit

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NAK

Prescription Use : No

Device Count : 1

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