Wallac Oy

Address:MUSTIONKATU 6,TURKU Varsinais-Suomi,FI

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- Catalog Number : B138-100

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 : B083-212

Device Description : Time-resolved fluoroimmunoassay for the quantitative determination of unconjugat Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : CGI

Prescription Use : No

Device Count : 1

- Catalog Number : B083-C01

Device Description : Time-resolved fluoroimmunoassay for the quantitative determination of unconjugat Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : CGI

Prescription Use : No

Device Count : 1

- Catalog Number : 1420-021

Device Description : VICTOR2 D will primarly be used for measuring test kits supplied by Wallac espec VICTOR2 D will primarly be used for measuring test kits supplied by Wallac especially for neonatal tests. Secondly VICTOR2 D can also be used for other measurements of TRF and prompt fluorescence. The user is a laboratory running screening on newborns or a general clinical chemistry lab running different hormones on blood samples.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : KHO

Prescription Use : Yes

Device Count : 1

- Catalog Number : A032-310

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

- Catalog Number : B032-312

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

- Catalog Number : 4010-0010

Device Description : For use with the DELFIA® Platewash after dilution with deionized water.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5002-0130

Device Description : Specimen Gate® PatientCare™ is intended for management of the follow-up workflow Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5002-0180

Device Description : Specimen Gate® Laboratory is a modular laboratory information management system Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : Yes

Device Count : 1

- Catalog Number : B032-02C

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