Manufacturer's Devices - Wallac Oy

Address:




Mustionkatu 6



Turku

20750

Finland


Authorised Representative/ UK Responsible Person
Name: Perkinelmer Ltd
Address:

Chalfont Road Seer Green



Beaconsfield

Bucks HP9 2FX

United Kingdom




Code/Term Type
Multiple amino acid/carnitine metabolite IVD kit mass spectrometryMultiple amino acid/carnitine metabolite IVD kit mass spectrometryIVD Annex II List B
Pregnancy-associated plasma protein A (PAPP-A) IVD kit fluorescence immunoassayPregnancy-associated plasma protein A (PAPP-A) IVD kit fluorescence immunoassayIVD Annex II List B
Trisomy 21 (Down syndrome) IVD controlTrisomy 21 (Down syndrome) IVD controlIVD Annex II List B
Congenital defect/syndrome risk assessment interpretive software IVDCongenital defect/syndrome risk assessment interpretive software IVDIVD Annex II List B
Newborn metabolic screen/congenital disorder IVD kit mass spectrophotometryNewborn metabolic screen/congenital disorder IVD kit mass spectrophotometryIVD General
Neonatal trypsin IVD kit fluorescent immunoassayNeonatal trypsin IVD kit fluorescent immunoassayIVD General
Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD controlSoluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD controlIVD General
Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD kit fluorescent immunoassaySoluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD kit fluorescent immunoassayIVD General
17-Hydroxyprogesterone IVD kit fluorescent immunoassay17-Hydroxyprogesterone IVD kit fluorescent immunoassayIVD General
Creatine kinase skeletal muscle isoenzyme (CKMM) IVD kit fluorescent immunoassayCreatine kinase skeletal muscle isoenzyme (CKMM) IVD kit fluorescent immunoassayIVD General
Free thyroxine (FT4) IVD kit fluorescent immunoassayFree thyroxine (FT4) IVD kit fluorescent immunoassayIVD General
Total thyroxine (TT4) IVD kit fluorescent immunoassayTotal thyroxine (TT4) IVD kit fluorescent immunoassayIVD General
SARS-CoV-2 nucleic acid IVD controlSARS-CoV-2 nucleic acid IVD controlIVD General
Multiple primary immunodeficiency/congenital muscular disorder IVD kit nucleic acid technique (NAT)Multiple primary immunodeficiency/congenital muscular disorder IVD kit nucleic acid technique (NAT)IVD General
Neonatal thyroid stimulating hormone (neonatal TSH) IVD kit fluorescent immunoassayNeonatal thyroid stimulating hormone (neonatal TSH) IVD kit fluorescent immunoassayIVD General
T-cell receptor excision circle (TREC) IVD kit nucleic acid technique (NAT)T-cell receptor excision circle (TREC) IVD kit nucleic acid technique (NAT)IVD General
Total human chorionic gonadotropin (HCG) IVD kit fluorescent immunoassayTotal human chorionic gonadotropin (HCG) IVD kit fluorescent immunoassayIVD General
Luteinizing hormone (LH) IVD kit enzyme immunoassay (EIA)Luteinizing hormone (LH) IVD kit enzyme immunoassay (EIA)IVD General
Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassayThyroid stimulating hormone (TSH) IVD kit fluorescent immunoassayIVD General
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit enzyme fluorescenceRed cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit enzyme fluorescenceIVD General
Human genomic analysis interpretive software IVDHuman genomic analysis interpretive software IVDIVD General
Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)IVD Annex II List B
Placental growth factor (PLGF) IVD kit fluorescent immunoassayPlacental growth factor (PLGF) IVD kit fluorescent immunoassayIVD Annex II List B
Trisomy 21-risk hormone IVD kit fluorescent immunoassayTrisomy 21-risk hormone IVD kit fluorescent immunoassayIVD Annex II List B
Multiple amino acid/carnitine metabolite IVD kit mass spectrometryMultiple amino acid/carnitine metabolite IVD kit mass spectrometryIVD General
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple haemoglobin subtype IVD kit electrophoresisMultiple haemoglobin subtype IVD kit electrophoresisIVD General
Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)IVD General
Magnetic particle separation instrument IVDMagnetic particle separation instrument IVDIVD General
Isothermal nucleic acid amplification analyser IVD laboratoryIsothermal nucleic acid amplification analyser IVD laboratoryClass A
Specimen processing instrument IVDSpecimen processing instrument IVDClass A
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDClass A
Multiple haemoglobin subtype IVD kit electrophoresisMultiple haemoglobin subtype IVD kit electrophoresisClass A
Fluorescent immunoassay analyser IVD laboratoryFluorescent immunoassay analyser IVD laboratoryClass A
Electrophoresis analyser IVDElectrophoresis analyser IVDClass A
Mass spectrometry analyser IVDMass spectrometry analyser IVDClass A
Microarray analyser IVDMicroarray analyser IVDClass A
Buffered wash solution IVD automated/semi-automated systemBuffered wash solution IVD automated/semi-automated systemClass A
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemClass A
Fluorescent immunoassay dissociation-enhancement reagent IVDFluorescent immunoassay dissociation-enhancement reagent IVDClass A
Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT)Class A
Magnetic particle separation instrument IVDMagnetic particle separation instrument IVDClass A
Microfilter imaging plate IVDMicrofilter imaging plate IVDClass A
Laboratory shaker IVDLaboratory shaker IVDClass A