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Wallac Oy

Finland·FI-MF-000022620

Last updated September 17, 2026

Information

Country: Finland
Address: 6, Mustionkatu, Turku, Finland
Website: www.revvity.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +3582 2678111
PRRC Contact: Noora Mäkelä
EUDAMED SRN: FI-MF-000022620
FDA FEI Number: 3002808498
DUNS Number: 540156544

Catalogue (157)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
DELFIA Neonatal hTSH Ultra kit	A042-201	EUDAMED	IVD General	Active
DELFIA hAFP	A096-101	EUDAMED	IVD Annex II List B	Active
DELFIA Xpress sFlt-1 kit	6009-001C	EUDAMED	IVD General	Active
LifeCycle Risk Calculation Engine	5015-8001	EUDAMED	Class C	Active
SARS-CoV-2 Plus (N/ORF1ab/E/S 69_70del) RT-qPCR Reagent kit	3515-0010	EUDAMED	IVD General	Active
DELFIA Enhancement Solution	1244-104	EUDAMEDFDA UDI	Class A	Active
Vanadis Core	2027-0020	EUDAMED	Class A	Active
RESOLVE Hb FASC Control Kit	3412-0010	EUDAMEDFDA UDI	IVD General	Active
DELFIA Neonatal IRT kit	A005-204	EUDAMED	IVD General	Active
Eonis Analysis Software	5020-1000	EUDAMEDFDA UDI	IVD General	Active
RESOLVE Hb Elution Solution	3024-0010	EUDAMEDFDA UDI	Class A	Active
DELFIA Neonatal IRT kit	A005-210	EUDAMED	IVD General	Active
DELFIA hCG	A082-101	EUDAMED	IVD Annex II List B	Active
DELFIA/AutoDELFIA Unconjugated Estriol (uE3) kit	B095-101	EUDAMED	IVD Annex II List B	Active
DELFIA Xpress PAPP-A	6003-0020	EUDAMED	IVD Annex II List B	Active
DELFIA Xpress PAPP-A	6003-002B	EUDAMED	IVD Annex II List B	Active
RESOLVE Hemoglobin Kit	FR-9360	EUDAMEDFDA UDI	IVD General	Active
DELFIA Xpress PAPP-A	6003-002C	EUDAMED	IVD Annex II List B	Active
GSP Neonatal 17α-OH-progesterone kit	3305-0010	EUDAMED	IVD General	Active
AutoDELFIA Automatic Immunoassay System	1235-5220	EUDAMEDFDA UDI	Class A	Active
NeoBase 2 Succinylacetone Assay Solution	3046-0010	EUDAMEDFDA UDI	IVD General	Active
MSMS Vitamin D Derivatization Box	3078-0010	EUDAMED	IVD General	Active
GSP, Genetic Screening Processor	2021-0010	EUDAMEDFDA UDI	Class A	Active
AutoDELFIA Inhibin A kit	B064-102	EUDAMED	IVD Annex II List B	Active
DELFIA/AutoDELFIA PAPP-A/Free hCGβ Dual DBS kit	B027-105	EUDAMED	IVD Annex II List B	Active
chemagic DNA Blood200 kit	3095-0030	EUDAMED	Class A	Active
DELFIA Free hCGß	A097-101	EUDAMED	IVD Annex II List B	Active
DELFIA Diluent 3	4022-0010	EUDAMEDFDA UDI	Class A	Active
DELFIA Wash Concentrate	4010-0010	EUDAMEDFDA UDI	Class A	Active
RESOLVE Hemoglobin Kit	FR-9400	EUDAMEDFDA UDI	IVD General	Active
DELFIA Wash Concentrate	1244-114	EUDAMEDFDA UDI	Class A	Active
Vanadis Core Buffer kit v2	3223-0020	EUDAMED	Class A	Active
Neonatal Total Galactose kit	3029-0010	EUDAMEDFDA UDI	IVD General	Active
DELFIA Xpress hCG kit	6004-001C	EUDAMED	IVD Annex II List B	Active
AutoDELFIA hTSH Ultra	B042-201	EUDAMED	IVD General	Active
DELFIA Diluent 3	4021-0010	EUDAMEDFDA UDI	Class A	Active
DELFIA/AutoDELFIA PlGF kit	B055-201	EUDAMED	IVD Annex II List B	Active
DELFIA Enhancement Solution	1244-105	EUDAMEDFDA UDI	Class A	Active
AutoDELFIA Automatic Immunoassay System	1235-5110	EUDAMEDFDA UDI	Class A	Active
BoBsoft	5012-0020	EUDAMED	IVD General	Active
AutoDELFIA Neonatal Thyroxine (T4)	B065-112	EUDAMEDFDA UDI	IVD General	Active
DELFIA hAFP/Free hCGß Dual	A067-101	EUDAMED	IVD Annex II List B	Active
Vanadis Core Buffer kit	3223-0010	EUDAMED	Class A	Active
NeoLSD LC-MSMS Assay Solutions	3257-0010	EUDAMED	Class A	Active
RESOLVE Hb Elution Solution	3025-0010	EUDAMEDFDA UDI	Class A	Active
Vanadis Extract Bind and Wash kit	3221-0010	EUDAMED	Class A	Active
DELFIA Wash Concentrate	B117-100	EUDAMEDFDA UDI	Class A	Active
AutoDELFIA hLH Spec kit	B031-101	EUDAMED	IVD General	Active
NeoBase Non-derivatized Assay Solutions	3041-0020	EUDAMEDFDA UDI	IVD Annex II List B	Active
sFlt-1 Controls	3246-0010	EUDAMED	IVD General	Active

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Wallac, Inc. US