Address:MUSTIONKATU 6,TURKU Varsinais-Suomi,FI
Device Description : Used with 1235-5220 AutoDELFIA® System (SP and PP).
Device Class : 1
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : No
Device Description : The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : Yes
Device Description : For DNA extraction from human plasma or blood.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : NeoBase™ 2 Non-derivatized Assay Solutions are intended for in vitro diagnostic NeoBase™ 2 Non-derivatized Assay Solutions are intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit to extract target analytes from blood samples dried on filter paper and to carry target analytes to the MSMS system.
Device Class : 2
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MSMS Workstation is intended for use as a calculator/data processing softwar The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : Yes
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes