Manufacturer

Labsystems Diagnostics

FinlandLegal entities : Labsystems Diagnostics Oy

Markets : Finland · United States

Approvals : EU – class A · United States (FDA) – · class I

13 categories, 19 models including 19 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Mycoplasma antibody assays	W0105010802	MYCOPLASMA PNEUMONIAE IgA EIA98/79 MYCOPLASMA PNEUMONIAE IgG EIA98/79 Mycoplasma pneumoniae IgM EIA98/79	– 98/79	EUDAMED record Report an error
Various sample processing instruments - hardware accessories	W02069080	NS Washer 5410100 NS496 Plus 5450300 NS96 Disc Remover 55503002 refs	A IVDR	EUDAMED record Report an error
Chlamydia pneumoniae antibody igm	W0105010116	Biocard Chlamydia pneumoniae IgM98/79 Chlamydia pneumoniae IgM EIA 611132098/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Biocard Helicobacter pylori IgG98/79 Biocard™ H pylori IgG Home 3-018-20098/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - high routine (throughput > 700 test/h)	W0201020104	NS2400 5400200	A IVDR	EUDAMED record Report an error
Chlamydia pneumoniae antibody iga	W0105010114	Chlamydia pneumoniae IgA EIA98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae antibody igg	W0105010115	Chlamydia pneumoniae IgG EIA98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody iga	W0105010109	Chlamydia trachomatis IgA EIA98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody igg	W0105010110	Chlamydia trachomatis IgG EIA98/79	– 98/79	EUDAMED record Report an error
H. pylori reagents - other	W0105010499	Biocard™ Helicobacter pylori Urease98/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	NS Reader 5420100	A IVDR	EUDAMED record Report an error
Mycobacterial antibody assays	W0105010702	Biocard Mycoplasma pneumoniae IgM 3-035-00098/79	– 98/79	EUDAMED record Report an error
Toxoplasma antibody igm	W0105050103	Neonatal Toxoplasma gondii IgM FEIA98/79	– 98/79	EUDAMED record Report an error

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