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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 1 of 4

Device	Model / Reference	Registries	Class	Status
Victor2 D	1420-020	EUDAMEDFDA UDI	Class A	Active
DELFIA/AutoDELFIA PlGF 1-2-3	B055-301	EUDAMED	IVD Annex II List B	Active
PlGF Controls	3090-0010	EUDAMED	IVD Annex II List B	Active
Neonatal Phenylalanine	NP-1000	EUDAMEDFDA UDI	IVD Annex II List B	Active
DELFIA Neonatal hTSH	A032-310	EUDAMEDFDA UDI	IVD General	Active
AutoDELFIA hAFP	B096-101	EUDAMED	IVD Annex II List B	Active
chemagic DNA CS200 kit	3207-0010	EUDAMEDFDA UDI	Class A	Active
AutoDELFIA PAPP-A	B098-201	EUDAMED	IVD Annex II List B	Active
AutoDELFIA hAFP/Free hCGß Dual	B067-101	EUDAMED	IVD Annex II List B	Active
Vanadis Extract Reagent kit	3220-0010	EUDAMED	Class A	Active
QSight 225 MD UHPLC Screening System	2040-0030	EUDAMEDFDA UDI	Class A	Active
GSP Wash Concentrate	4080-0010	EUDAMEDFDA UDI	Class A	Active
DELFIA Xpress uE3	6005-0010	EUDAMED	IVD Annex II List B	Active
Vanadis View	2028-0020	EUDAMED	Class A	Active
DELFIA Xpress hAFP	6001-001C	EUDAMED	IVD Annex II List B	Active
GSP Neonatal G6PD kit	3310-0010	EUDAMED	IVD General	Active
Vanadis Core Reagent Cartridge II	3222-002B	EUDAMED	Class C	Active
NeoLSD 7plex LC-MSMS kit	3256-0010	EUDAMED	Class C	Active
Delfia Digoxin Kit	K924594	FDA 510(k)	Class II	Active
Gsp Neonatal 17a-Oh-Progesterone Kit Model: 3305-001u	K100682	FDA 510(k)	Class I	Active
Delfia Neonatal Irt Kit, Model A005-110	K003664	FDA 510(k)	Class II	Active
Autodelfia Neonatal Irt L Kit, Model B022-112	K070889	FDA 510(k)	Class II	Active
Delfia(r) Hgh Kit	K930484	FDA 510(k)	Class I	Active
Resolve Hemoglobin Kit, Jb-2 Staining System, Models Fr-9120, Fr-9400, Fr-9360, Fr-9367	K050709	FDA 510(k)	Class II	Active
Modification To: Autodelfia Neonatal 17a-Oh-Progesterone L Kit	K050960	FDA 510(k)	Class I	Active
Delfia Cortisol Kit	K930732	FDA 510(k)	Class II	Active
Autodelfia Neonatal 17a-Oh-Progesterone Kit	K042425	FDA 510(k)	Class I	Active
Delfia Testtosterone Kit	K932951	FDA 510(k)	Class I	Active
Delfia Neonatal 17a-Oh-Progesterone Kit	K042424	FDA 510(k)	Class I	Active
Delfia Neonatal Thyroxine Kit	K943416	FDA 510(k)	Class II	Active
Perkinelmer Enlite Neonatal Trec Test System	DEN140010	FDA 510(k)	Class II	Active
Autodelfia Neonatal 17a-Oh-Progesterone Kit	K081922	FDA 510(k)	Class I	Active
Delfia Shbg Kit	K940449	FDA 510(k)	Class I	Active
Autodelfia Neonatal Irt Kit, Model B005-112	K003668	FDA 510(k)	Class II	Active
GSP Neonatal Thyroxine (T4) kit	3302-0010	EUDAMED	IVD General	Active
Panthera-Puncher 9	2081-0010	EUDAMEDFDA UDI	Class A	Active
Neonatal GALT	NG-1100	EUDAMEDFDA UDI	IVD General	Active
JB-2 Staining System	FR-9367	EUDAMEDFDA UDI	Class A	Active
EnLite Neonatal TREC kit	3401-0010	EUDAMED	IVD General	Active
Neonatal GALT	NG-4100	EUDAMEDFDA UDI	IVD General	Active
BoBsoft	5012-0202	EUDAMED	IVD General	Active
GSP Neonatal hTSH kit	3301-0010	EUDAMED	IVD General	Active
DELFIA Neonatal Thyroxine (T4)	A065-110	EUDAMEDFDA UDI	IVD General	Active
DELFIA Neonatal hTSH	A032-303	EUDAMED	IVD General	Active
AutoDELFIA Neonatal 17α-OH-progesterone kit	B024-112	EUDAMEDFDA UDI	IVD General	Active
GSP®/DELFIA® Anti-SARS-CoV-2 IgG kit	3503-0020	EUDAMED	IVD General	Active
GSP Neonatal Phenylalanine kit	3308-0010	EUDAMED	IVD Annex II List B	Active
CHS MSMS Steroids kit	3070-0020	EUDAMED	IVD General	Active
PKamp Respiratory SARS-CoV-2 RT-PCR Panel kit	3504-0010	EUDAMED	IVD General	Active
DELFIA Diluent II	B131-100	EUDAMEDFDA UDI	Class A	Active

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Wallac, Inc. US