Wallac Oy

Address:MUSTIONKATU 6,TURKU Varsinais-Suomi,FI

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Device Description : Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried blood.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : CDX

Prescription Use : No

Device Count : 1

- 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

- 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

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

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

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

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

Device Description : The product is to be used together with the NeoGram Amino Acids and Acylcarnitin The product is to be used together with the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry kit, and is intended for the measurement of amino acid, free carnitine, and acylcarnitine 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 : No

Device Count : 1

- Catalog Number : 3018-0010

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

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NAK

Prescription Use : No

Device Count : 1

- Catalog Number : 3018-001B

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

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NAK

Prescription Use : No

Device Count : 1