Manufacturer

DiaSorin

Italy, United Kingdom (ex Northern Ireland), United StatesLegal entities : DiaSorin Inc., DiaSorin Italia S.p.A UK Branch, DiaSorin Italia S.p.A.

Markets : Denmark · France · Italy · Netherlands · Spain · Sweden · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 88 · PMA : 23 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : Italy 24 · Spain 6 · France 5 · Netherlands 1 · Sweden 1

EU representative : DiaSorin Italia S.p.A. (Italy)

Website ivdr_dsu@diasorin.com

82 categories, 181 models including 181 on the market, 3 countries

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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
Other virology controls - inf.imm.	W0105080804	LIAISON® Adenovirus Control Set98/79 LIAISON® Biotrin Control Parvovirus B19 IgG98/79 LIAISON® Biotrin Control Parvovirus B19 IgG Plus LIAISON® Biotrin Control Parvovirus B19 IgM98/79 LIAISON® Biotrin Control Parvovirus B19 IgM Plus 22 others LIAISON® Control CMV IgG Avidity II LIAISON® Control CMV IgG II98/79 LIAISON® Control EA IgG LIAISON® Control EBNA IgG LIAISON® Control EBV IgM LIAISON® Control HSV-1 IgG98/79 LIAISON® Control HSV-1/2 IgG LIAISON® Control HSV-1/2 IgM98/79 LIAISON® Control HSV-2 IgG LIAISON® Control Measles IgM LIAISON® Control Mumps IgG98/79 LIAISON® Control Mumps IgM LIAISON® Control Rubella IgG98/79 LIAISON® Control Rubella IgG II LIAISON® Control Rubella IgM LIAISON® Control SARS-CoV-2 Ag LIAISON® Control VCA IgG LIAISON® Control VZV IgG98/79 LIAISON® Control VZV IgG HT LIAISON® Control VZV IgM LIAISON® Rotavirus Control Set98/79 LIAISON® SARS-CoV-2 TrimericS IgG Control Set98/79	B, C IVDR, 98/79	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	LIAISON® C. difficile GDH Control Set98/79 LIAISON® C. difficile Toxins A&B Control Set98/79 LIAISON® Control Bordetella pertussis Toxin IgA LIAISON® Control Bordetella pertussis Toxin IgG LIAISON® Control Borrelia IgG 14 others LIAISON® Control Borrelia IgG Liquor LIAISON® Control Borrelia IgM Liquor LIAISON® Control Borrelia IgM Quant / Borrelia IgM II LIAISON® Control Chlamydia trachomatis IgA LIAISON® Control Chlamydia trachomatis IgG LIAISON® Control Legionella Urinary Ag LIAISON® Control LymeDetect® LIAISON® Control Mycoplasma pneumoniae IgG98/79 LIAISON® Control Mycoplasma pneumoniae IgM LIAISON® Control QuantiFERON®-TB Gold Plus2 refs LIAISON® Control QuantiFERON®-TB Gold Plus II LIAISON® Control S. pneumoniae Ag LIAISON® H. pylori IgG Control Set98/79 LIAISON® Meridian H. pylori SA Control Set98/79	B, C IVDR, 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - consumables	W0201020185	LIAISON® BAP OSTASE® Specimen Diluent LIAISON® BRAHMS PCT® II GEN Samples diluent LIAISON® Cleaning Kit LIAISON® Disposable Tips LIAISON® EASY Cleaning Tool 9 others LIAISON® EASY Starter Kit LIAISON® EASY System Liquid LIAISON® EASY Wash Buffer LIAISON® Light Check 12 LIAISON® Starter Kit LIAISON® Wash/System Liquid LIAISON® XL Cleaning Tool LIAISON® XL Disposable Tips LIAISON® XL Starter Kit	A IVDR	EUDAMED record Report an error
All infectious diseases controls - NAT	W0105080808	Simplexa™ Bordetella Positive Control Pack98/79 Simplexa™ COVID-19 & Flu A/B Positive Control Pack98/79 Simplexa™ COVID-19 / Flu A/B & RSV Positive Control Pack Simplexa™ COVID-19 Positive Control Pack98/79 Simplexa™ Flu A/B & RSV Positive Control Pack98/79 2 others Simplexa™ Group A Strep Positive Control Pack98/79 Simplexa™ HSV 1 & 2 Positive Control Pack98/79	B IVDR, 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Anaplasma phagocytophilum IFA IgM98/79 Anaplasma phagocytophilum IFA IgG98/79 Bartonella IFA IgG98/79 Bartonella IFA IgM98/79	– 98/79	EUDAMED record Report an error
Hepatitis virus controls - inf.imm.	W0105080802	LIAISON® Control Anti-HAV LIAISON® MUREX Control Anti-HEV IgG LIAISON® MUREX Control Anti-HEV IgM LIAISON®Control HAV lgM98/79	B, C IVDR, 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - hardware accessories	W02050180	Accessory Box MOL1100 Simplexa™ Direct Amplification Disc Simplexa™ Universal Disc Universal Disc Cover Tape MOL1500	A IVDR	EUDAMED record Report an error
Parvovirus b 19	W0105040609	LIAISON® Biotrin Parvovirus B19 IgG98/79 LIAISON® Biotrin Parvovirus B19 IgG Plus LIAISON® Biotrin Parvovirus B19 IgM98/79 LIAISON® Biotrin Parvovirus B19 IgM Plus	C IVDR, 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	ETI-Max 3000 LIAISON® XL LIAISON® XL LAS	A IVDR	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	Simplexa™ C. Difficile Sample Prep Kit Simplexa™ C. difficile Direct98/79 Simplexa™ C. difficile Universal Direct98/79	A IVDR, 98/79	EUDAMED record Report an error
Parasitology controls - inf.imm.	W0105080805	LIAISON® Control Toxo IgG II LIAISON® Control Toxo IgM LIAISON® XL Control Toxo IgG Avidity	C IVDR	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	LIAISON® Cuvettes on tray LIAISON® Module LIAISON® XL Cuvettes	A IVDR	EUDAMED record Report an error
Bordetella pertussis / parapertussis	W0105011707	LIAISON® Bordetella pertussis Toxin IgA LIAISON® Bordetella pertussis Toxin IgG	B IVDR	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Simplexa™ Bordetella Direct98/79 Simplexa™ Bordetella Universal Direct2 refs98/79	– 98/79	EUDAMED record Report an error
Cmv - NA reagents	W0105040205	Simplexa™ Congenital CMV Direct Simplexa™ Congenital CMV Positive Control Pack	C IVDR	EUDAMED record Report an error
Controls - inf. immunology - other	W0105080899	Simplexa™ Extraction & Amplification Control Set2 refs98/79 Simplexa™ Extraction & Amplification Control Set - RNA98/79	– 98/79	EUDAMED record Report an error
Coxiella burnetii (q fever)	W0105011703	Q Fever IFA IgG98/79 Q Fever IFA IgM98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igg	W0105040303	HerpeSelect® 1 and 2 Immunoblot IgG98/79 LIAISON® HSV-1/2 IgG	C IVDR, 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	HerpeSelect® 2 ELISA IgG98/79 LIAISON® HSV-2 IgG	C IVDR, 98/79	EUDAMED record Report an error
Lyme antibody igm	W0105010604	LIAISON® Borrelia IgM II LIAISON® Borrelia IgM Quant	B IVDR	EUDAMED record Report an error
Mycobacteria reagents - other	W0105010799	LIAISON® QuantiFERON®-TB Gold Plus2 refs LIAISON® QuantiFERON®-TB Gold Plus II2 refs	C IVDR, 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	LIAISON® Mycoplasma pneumoniae IgG98/79 LIAISON® Mycoplasma pneumoniae IgM	B IVDR, 98/79	EUDAMED record Report an error
Rickettsia	W0105011705	Rickettsia IFA IgG98/79 Rickettsia IFA IgM98/79	– 98/79	EUDAMED record Report an error
Rubella virus igg	W0105040102	LIAISON® Rubella IgG98/79 LIAISON® Rubella IgG II	C IVDR, 98/79	EUDAMED record Report an error
Samples analyses, plastic tubes with additives	W050301020101	LIAISON® Q.S.E.T. Device Plus LIAISON® Q.S.E.T. Quick Pick	A IVDR	EUDAMED record Report an error
Varicella zoster - NA reagents	W0105040904	Simplexa™ VZV Direct98/79 Simplexa™ VZV Swab Direct98/79	– 98/79	EUDAMED record Report an error
Varicella zoster virus igg	W0105040902	LIAISON® VZV IgG98/79 LIAISON® VZV IgG HT	C IVDR, 98/79	EUDAMED record Report an error
Various general purpose IVD instruments - software accessories	W02079082	LIAISON® ASYc98/79 LIAISON® QuantiFERON® Software98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	LIAISON® Adenovirus98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - hardware accessories	W0201020180	LIAISON® Xcelerator	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	LIAISON® XS	A IVDR	EUDAMED record Report an error
Blood collection, tubes with additives or serum separator	W050101010201	LIAISON® QuantiFERON® LymeDetect® Blood Collection Tubes	A IVDR	EUDAMED record Report an error
Buffers (unassignable ), supplem. reagents, etc	W0105900201	LIAISON® SARS-CoV-2 Sample Inactivation Buffer	A IVDR	EUDAMED record Report an error
C.difficile GDH detection	W0105011801	LIAISON® C. difficile GDH98/79	– 98/79	EUDAMED record Report an error
C.difficile toxin a/b detection	W0105011802	LIAISON® C. difficile Toxins A&B98/79	– 98/79	EUDAMED record Report an error
Campylobacter direct antigen detection	W0105011401	LIAISON® Campylobacter Ag98/79	– 98/79	EUDAMED record Report an error
Campylobacter reagents - other	W0105011499	LIAISON® Campylobacter Ag Control Set98/79	– 98/79	EUDAMED record Report an error
Candida auris - NA reagents	W0105060404	Simplexa™ C. auris Direct	C IVDR	EUDAMED record Report an error
Chlamydia trachomatis antibody iga	W0105010109	LIAISON® Chlamydia trachomatis IgA	C IVDR	EUDAMED record Report an error
Chlamydia trachomatis antibody igg	W0105010110	LIAISON® Chlamydia trachomatis IgG	C IVDR	EUDAMED record Report an error
Cmv igg	W0105040203	LIAISON® CMV IgG II98/79	– 98/79	EUDAMED record Report an error
Cmv igg - avidity	W0105040206	LIAISON® CMV IgG Avidity II	C IVDR	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	Simplexa™ COVID-19 Direct98/79	– 98/79	EUDAMED record Report an error
Coronavirus ag	W0105041101	LIAISON® SARS-CoV-2 Ag	B IVDR	EUDAMED record Report an error
Coronavirus igg	W0105041103	LIAISON® SARS-CoV-2 TrimericS IgG98/79	– 98/79	EUDAMED record Report an error
Diluters	W02079002	LIAISON® diluteX	A IVDR	EUDAMED record Report an error
Ebv ea igg	W010504040108	LIAISON® EA IgG	B IVDR	EUDAMED record Report an error
Ebv ebna igg	W010504040106	LIAISON® EBNA IgG	B IVDR	EUDAMED record Report an error
Ebv igm - total	W010504040103	LIAISON ® EBV IgM	B IVDR	EUDAMED record Report an error
Ebv vca igg	W010504040105	LIAISON® VCA IgG	B IVDR	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	LIAISON® H. pylori IgG98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	LIAISON® Meridian H. pylori SA98/79	– 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	LIAISON® Anti-HAV	B IVDR	EUDAMED record Report an error
Hav antibody igm	W0105020104	LIAISON® HAV IgM98/79	– 98/79	EUDAMED record Report an error
HBV reagents - other	W0105020299	LIAISON® XL Murex HBsAg Quant Specimen Diluent	A IVDR	EUDAMED record Report an error
Hev antibody igg	W0105020504	LIAISON® MUREX Anti-HEV IgG	C IVDR	EUDAMED record Report an error
Hev antibody igm	W0105020505	LIAISON® MUREX Anti-HEV IgM	C IVDR	EUDAMED record Report an error
Hsv 1 igg	W0105040306	LIAISON® HSV-1 Type Specific IgG98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igm	W0105040304	LIAISON® HSV-1/2 IgM98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Heating Blocks 5F09-02	A IVDR	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Simplexa™ COVID-19 / Flu A/B & RSV Direct	B IVDR	EUDAMED record Report an error
Jc virus	W0105040623	STRATIFY JCV® DxSelect™98/79	– 98/79	EUDAMED record Report an error
Legionella antigen detection	W0105010501	LIAISON® Legionella Urinary Ag	C IVDR	EUDAMED record Report an error
Lyme antibody igg	W0105010603	LIAISON® Borrelia IgG	B IVDR	EUDAMED record Report an error
Lyme borreliosis reagents - other	W0105010699	LIAISON® LymeDetect®	B IVDR	EUDAMED record Report an error
Measles virus igm	W0105040703	LIAISON® Measles IgM	C IVDR	EUDAMED record Report an error
Mumps / parotitis virus igg	W0105040802	LIAISON® Mumps IgG98/79	– 98/79	EUDAMED record Report an error
Mumps / parotitis virus igm	W0105040803	LIAISON® Mumps IgM	B IVDR	EUDAMED record Report an error
Mycology controls - inf.imm.	W0105080806	Simplexa™ C. auris Positive Control Pack	C IVDR	EUDAMED record Report an error
Nucleic acid hybridization units	W02050101	LIAISON® MDX	A IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables	W02050185	Simplexa™ Spectral Calibration Panel	A IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - software accessories	W02050182	Laptop with LIAISON® MDX Studio Software	A IVDR	EUDAMED record Report an error
Rotavirus	W0105040606	LIAISON® Rotavirus98/79	– 98/79	EUDAMED record Report an error
Rubella virus igm	W0105040103	LIAISON® Rubella IgM	C IVDR	EUDAMED record Report an error
Samples analyses, plastic tubes - accessories	W050301020180	LIAISON® Stool Extraction Device	A IVDR	EUDAMED record Report an error
Strep. b detection by NA reagents	W0105011104	Simplexa™ GBS Direct98/79	– 98/79	EUDAMED record Report an error
Streptococcal direct antigen detection	W0105011101	LIAISON® S. pneumoniae Ag	C IVDR	EUDAMED record Report an error
Toxoplasma antibody igg	W0105050102	LIAISON® Toxo IgG II	C IVDR	EUDAMED record Report an error
Toxoplasma antibody igg - avidity	W0105050104	LIAISON® XL Toxo IgG Avidity	C IVDR	EUDAMED record Report an error
Toxoplasma antibody igm	W0105050103	LIAISON® Toxo IgM	C IVDR	EUDAMED record Report an error
Varicella zoster virus igm	W0105040903	LIAISON® VZV IgM	C IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	Simplexa™ Flu A/B & RSV Direct Gen II98/79	– 98/79	EUDAMED record Report an error

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