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Sign in to claim this brandLabsystems 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
- —
- [email protected]
- Phone
- +358 20 155 7530
- PRRC Contact
- Päivi Myllyniemi
- EUDAMED SRN
- FI-MF-000018281
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (69)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeoNat SCID-SMA Real-Time PCR Kit | 8100481 | EUDAMED | IVD General | Active |
| Biocard Mycoplasma pneumoniae IgM | 3-035-000 | EUDAMED | IVD General | Active |
| NeoMass AAAC Plus Extraction Solution B | 710011009 | EUDAMED | IVD Annex II List B | Active |
| Mycoplasma pneumoniae IgM EIA | 6111420 | EUDAMED | IVD General | Active |
| VAE-Control set (Low) | 72500334 | EUDAMED | IVD General | Active |
| Neonatal 17-OH-Progesterone FEIA | 6199871 | EUDAMED | IVD General | Active |
| Neomass Aaac Plus | 7100110 | EUDAMED | IVD Annex II List B | Active |
| MYCOPLASMA PNEUMONIAE IgA EIA | 6111410 | EUDAMED | IVD General | Active |
| Neonatal Phenylalanine | 6199896 | EUDAMED | IVD Annex II List B | Active |
| COVID-19 Real Time Multiplex RT-PCR Kit | 8100513 | EUDAMED | IVD General | Active |
| MYCOPLASMA PNEUMONIAE IgG EIA | 6111400 | EUDAMED | IVD General | Active |
| Neonatal IRT FEIA | 6199831 | EUDAMED | IVD General | Active |
| Respiratory Multiplex RT-PCR Kit | 8100532 | EUDAMED | IVD General | Active |
| NeoMass AAAC 3.0 | NeoMass AAAC 3.0 | EUDAMED | IVD Annex II List B | Active |
| NeoMass CAH Multilevel Controls, Dried Blood Spot Controls Level 1-3 | 3467701 | EUDAMED | IVD General | Active |
| NeoNat SCID Real-Time PCR Kit | 8100443 | EUDAMED | IVD General | Active |
| NeoMass CAH Multilevel Calibrators, Dried Blood Spot Calibrators Level 0-7 | 3467700 | EUDAMED | IVD General | Active |
| Biocard™ H pylori IgG Home | 3-018-200 | EUDAMED | IVD devices for self-testing | Active |
| NeoMass AAAC Plus Internal Standard - Labelled Succinylacetone (ISTD - SUAC) | 710011006 | EUDAMED | IVD General | Active |
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