Wallac Oy

Address:MUSTIONKATU 6,TURKU Varsinais-Suomi,FI

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Device Description : For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JLX

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JLX

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JLX

Prescription Use : Yes

Device Count : 1

Device Description : This reagent package is intended for sample processing in the assay of in vitro This reagent package is intended for sample processing in the assay of in vitro measurement and evaluation of the concentrations of amino acids, succinylacetone and acylcarnitines in dried blood spot samples (DBS) on filter paper.This reagent package is used together with the NeoBase Non-derivatized MSMS Kit and the NeoBase Succinylacetone Assay Solution.

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NQL

Prescription Use : No

Device Count : 1

Device Description : The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase Non-derivatized MSMS Kit and the NeoBase non-derivatized Assay Solutions. The NeoBase™ Succinylacetone Assay Solution is used for the measurement and evaluation of succinylacetone concentration from blood samples dried on filter paper (DBS).

Device Class : 2

Duns Number: 540156544

Premarket Exempt : No

Product Code : NQL

Prescription Use : No

Device Count : 1

- Catalog Number : 1296-0050

Device Description : The TriNEST™ microplate incubator and shaker is intended for use in laboratories The TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : JRQ

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JNO

Prescription Use : No

Device Count : 1

Device Description : For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : No

Product Code : JNO

Prescription Use : No

Device Count : 1

- Catalog Number : 3304-0010

Device Description : For the quantitative determination of europium (Eu³⁺) in dissociation-enhanced t For the quantitative determination of europium (Eu³⁺) in dissociation-enhanced time-resolved fluoroimmunoassays.

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

- Catalog Number : 4080-0010

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

Device Class : 1

Duns Number: 540156544

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1