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Labsystems Diagnostics Oy

Finland·FI-MF-000018281

Last updated September 18, 2026

About

Labsystems Diagnostics Oy develops, manufactures and markets high quality diagnostic solutions for neonatal

From the manufacturer's own website. Source

What Labsystems Diagnostics Oy makes

Labsystems Diagnostics Oy produces lyophilized and reagent-based diagnostic kits for genetic and metabolic testing, including solutions for congenital adrenal hyperplasia (CAH) screening and internal standards for amino acid analysis. Their portfolio also includes real-time PCR kits for neonatal genetic disorders such as severe combined immunodeficiency (SCID) and spinal muscular atrophy (SMA), as well as multiplex PCR assays for infectious disease detection, such as COVID-19. Additional offerings encompass plasma/serum assays for vitamins A and E and control sets for diagnostic validation.

The company’s diagnostic devices fall under Class A and In Vitro Diagnostic (IVD) classifications, including Annex II List B and general IVD categories, with some designated for self-testing. These products are registered in the EU’s eudamed database, adhering to EU regulatory requirements for medical devices. The manufacturer is based in Finland.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Finland
Address: 3, Tiilitie , Vantaa, Finland
Website: www.labsystemsdx.com
LinkedIn: linkedin.com/company/labsystemsdiagnostics
Facebook: —
Email: [email protected]
Phone: +358 20 155 7530
PRRC Contact: Päivi Myllyniemi
EUDAMED SRN: FI-MF-000018281
FDA FEI Number: —
DUNS Number: —

Catalogue (69)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
NeoMass CAH Tuning Mixture (lyophilized)	3467708	EUDAMED	IVD General	Active
NeoNat SCID Real-Time PCR Kit	8100442	EUDAMED	IVD General	Active
NeoMass CAH Rinsing Solution	3467706	EUDAMED	IVD General	Active
NeoMass CAH Reconstitution Solution	3467703	EUDAMED	IVD General	Active
Ns2400	5400200	EUDAMED	Class A	Active
NeoMass CAH Extraction Solution with Internal Standard	3467702	EUDAMED	IVD General	Active
NeoMass AAAC Plus Internal standard – Labelled Amino Acids (ISTD – AA)	710011004	EUDAMED	IVD Annex II List B	Active
Vitamin A and E in plasma / serum	7250033	EUDAMED	IVD General	Active
NeoNat SCID-SMA Multiplex Real-Time PCR Kit	8100411	EUDAMED	IVD General	Active
COVID-19 Real Time Multiplex RT-PCR Kit	8100512	EUDAMED	IVD General	Active
VAE-Control Set (Low + High Control)	72500333	EUDAMED	IVD General	Active
NeoNat SMA Real-Time PCR Kit	8100461	EUDAMED	IVD General	Active
VAE- Serum Calibration Standard	3469877	EUDAMED	IVD General	Active
Biocard Chlamydia pneumoniae IgM	3-034-000	EUDAMED	IVD Annex II List B	Active
Chlamydia pneumoniae IgG EIA	6111300	EUDAMED	IVD Annex II List B	Active
Chlamydia trachomatis IgA EIA	6111111	EUDAMED	IVD Annex II List B	Active
NS496 Plus	5450300	EUDAMED	Class A	Active
Neonatal G6PD	6199860	EUDAMED	IVD General	Active
Chlamydia pneumoniae IgA EIA	6111310	EUDAMED	IVD Annex II List B	Active
VAE-Control set (High)	72500335	EUDAMED	IVD General	Active
Neonatal Biotinidase	6199821	EUDAMED	IVD General	Active
Neonatal Galactose	6199850	EUDAMED	IVD General	Active
Respiratory Multiplex RT-PCR Kit	8100533	EUDAMED	IVD General	Active
NeoMass CAH System Suitability Mixture (lyophilized)	3467709	EUDAMED	IVD General	Active
NeoMass CAH Mobile Phase A	3467704	EUDAMED	IVD General	Active
NeoMass CAH Mobile Phase B	3467705	EUDAMED	IVD General	Active
NS96 Disc Remover	5550400	EUDAMED	Class A	Active
Neonatal Phenylalanine Controls	6190930	EUDAMED	IVD Annex II List B	Active
NS Reader	5420100	EUDAMED	Class A	Active
Neonatal T4 FEIA	6199890	EUDAMED	IVD General	Active
Neonatal GALT	6199810	EUDAMED	IVD General	Active
Neonatal hTSH FEIA Plus	6199880	EUDAMED	IVD General	Active
Biocard Helicobacter pylori IgG	3-018-110	EUDAMED	IVD General	Active
NeoNat SCID-SMA Multiplex Real-Time PCR Kit	8100412	EUDAMED	IVD General	Active
Chlamydia pneumoniae IgM EIA	6111320	EUDAMED	IVD Annex II List B	Active
Neonatal Toxoplasma gondii IgM FEIA	6199802	EUDAMED	IVD Annex II List B	Active
NeoMass AAAC Plus Internal standard - Labelled Acylcarnitines (ISTD - AC)	710011005	EUDAMED	IVD General	Active
Neonatal Phenylalanine Calibrators	6190940	EUDAMED	IVD Annex II List B	Active
NeoNat SMA Real-Time PCR Kit	8100462	EUDAMED	IVD General	Active
Biocard™ Celiac Home	3-028-200	EUDAMED	IVD devices for self-testing	Active
NeoNat SCID-SMA Multiplex Real-Time PCR Kit	8100413	EUDAMED	IVD General	Active
NeoMass AAAC Plus Eluent Solution	710011010	EUDAMED	IVD Annex II List B	Active
NeoMass AAAC Plus Internal Standard - Labelled Argininosuccinic Acid (ISTD - ASA)	710011007	EUDAMED	IVD General	Active
NeoMass CAH	7150022	EUDAMED	IVD General	Active
Chlamydia trachomatis IgG EIA	6111101	EUDAMED	IVD Annex II List B	Active
Biocard™ Helicobacter pylori Urease	3-018-945	EUDAMED	IVD General	Active
VAE-Extraction Solution with Internal Standards	3469880	EUDAMED	IVD General	Active
NS Washer	5410100	EUDAMED	Class A	Active
NS96 Disc Remover	5550300	EUDAMED	Class A	Active
Blocard ™ Celiac Test	3-028-000	EUDAMED	IVD General	Active

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