Wallac Oy

Address:MUSTIONKATU 6,TURKU Varsinais-Suomi,FI

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Filters

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

Agglutination Method, Human Chorionic Gonadotropin (JHJ) (3) General Purpose Reagent (PPM) (3) Radioimmunoassay, Total Thyroxine (CDX) (2) Radioimmunoassay, Follicle-Stimulating Hormone (CGJ) (1) Radioimmunoassay, Luteinizing Hormone (CEP) (1)

Premarket Exempt

No Yes

Clear

DELFIA Wash Concentrate - 06438147005291 Catalog Number : 1244-114

Device Description : For use with the DELFIA® Platewash or the AutoDELFIA® automatic immunoassay system.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

DELFIA hCG kit - 06438147009176 Catalog Number : A007-101

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

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : JHJ

Prescription Use : No

Device Count : 1

DELFIA hFSH kit - 06438147009183 Catalog Number : A017-201

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

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : CGJ

Prescription Use : No

Device Count : 1

DELFIA hLH Spec kit - 06438147009206 Catalog Number : A031-101

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

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : CEP

Prescription Use : No

Device Count : 1

DELFIA Neonatal Thyroxine (T4) kit - 06438147009251 Catalog Number : A065-110

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

AutoDELFIA hCG kit - 06438147009336 Catalog Number : B007-101

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

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : JHJ

Prescription Use : No

Device Count : 1

AutoDELFIA hCG kit - 06438147009343 Catalog Number : B007-112

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

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : JHJ

Prescription Use : No

Device Count : 1

AutoDELFIA Neonatal Thyroxine (T4) kit - 06438147009589 Catalog Number : B065-112

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 Wash Concentrate - 06438147009718 Catalog Number : B117-100

Device Description : For use with the DELFIA® Platewash or the AutoDELFIA® automatic immunoassay system.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

DELFIA Enhancement Solution - 06438147009725 Catalog Number : B118-100

Device Description : For the quantitative determination of europium (Eu³⁺) and samarium (Sm³⁺) in dis

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

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