DiaSorin Italia S.p.A.

Registration Details

Registration Name: DiaSorin Italia S.p.A.
Registration Number: 9610240
FEI Number: 3002808212
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: VIA CRESCENTINO, snc
City: SALUGGIA Vercelli
Country: IT

Regulatory Submissions

510(k) Number: K132234
PMA Number: P970055

Owner / Operator

Firm Name: DiaSorin Inc.
Operator Number: 9051149
Address: 1951 Northwestern Ave
City: Stillwater
State: MN
Postal Code: 55082
Country: US
Correspondent: Mari Meyer

US Agent

Business Name: DiaSorin Inc.
Contact Name: Mari Meyer
Address: 1951 Northwestern Ave
City: Stillwater
State: MN
ZIP: 55082
Country: US
Email: [email protected]
Phone: 651 4939971

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	Class 2	Microbiology	No	2013-09-06
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm	MYM	Class 3	Unknown	No	2019-05-07
System, Test, Human Chorionic Gonadotropin	DHA	Class 2	Clinical Chemistry	No	2013-12-03
Radioimmunoassay, Human Growth Hormone	CFL	Class 1	Clinical Chemistry	No	1981-10-11
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg	MYL	Class 3	Unknown	No	2019-05-07
Analyzer, Chemistry, Micro, For Clinical Use	JJF	Class 1	Clinical Chemistry	No	2016-03-29
Hepatitis A Test (Antibody And Igm Antibody)	LOL	Class 2	Microbiology	No	2016-03-29
Research Use Only/Microbiology	OTT	Class N	Unknown	No	2012-05-24
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	Class 2	Microbiology	No	2020-09-03
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	Class 2	Microbiology	No	2020-09-03
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	LFY	Class 2	Microbiology	No	2023-12-07
Test, Hiv Detection	MZF	Class 2	Microbiology	No	2025-12-02
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis	NCD	Class 3	Unknown	No	2019-12-01
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	Class 2	Microbiology	No	2007-12-18
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	Class 2	Microbiology	No	2012-09-11
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2012-09-11
Radioimmunoassay, Angiotensin I And Renin	CIB	Class 2	Clinical Chemistry	No	2013-01-04
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	Class 1	Clinical Chemistry	No	1981-10-11
Radioimmunoassay, Free Thyroxine	CEC	Class 2	Clinical Chemistry	No	2013-04-09
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	LJB	Class 1	Microbiology	No	1995-03-27
Research Use Only/Immunology Devices	OTR	Class N	Unknown	No	2012-05-24
Reagents, Specific, Analyte	MVU	Class 1	Pathology	No	1999-01-06
Antigen, Inflammatory Response Marker, Sepsis	NTM	Class 2	Microbiology	No	2018-02-28
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	PMT	Class 2	Microbiology	No	2018-02-28
Procalcitonin Assay	PRI	Class 2	Microbiology	No	2018-02-28
Ferritin, Antigen, Antiserum, Control	DBF	Class 2	Immunology	No	2021-09-17
Epstein-Barr Virus, Other	LSE	Class 1	Microbiology	No	2017-03-21
Test, Antigen, Nuclear, Epstein-Barr Virus	LLM	Class 1	Microbiology	No	2017-03-21
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	Class 2	Microbiology	No	2007-12-18
Radioimmunoassay, Luteinizing Hormone	CEP	Class 1	Clinical Chemistry	No	1981-10-11
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2020-03-13
Device To Detect Antibodies To Hepatitis D Virus	SGW	Class 2	Immunology	No	2026-01-02
Radioimmunoassay, Total Triiodothyronine	CDP	Class 2	Clinical Chemistry	No	1995-03-24
Reagent, Coronavirus Serological	QKO	Class N	Unknown	No	2020-04-25
Radioimmunoassay, Prolactin (Lactogen)	CFT	Class 1	Clinical Chemistry	No	1979-03-15
Enzyme Linked Immunoabsorbent Assay, Mumps Virus	LJY	Class 1	Microbiology	No	2011-04-21
Coronavirus Antigen Detection Test System.	QKP	Class N	Unknown	No	2021-03-29
Real Time Nucleic Acid Amplification System	OOI	Class 2	Clinical Chemistry	No	2017-03-31
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	Class 2	Microbiology	No	2019-11-01
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	Class 1	Clinical Chemistry	No	1982-09-13
Radioimmunoassay, Immunoreactive Insulin	CFP	Class 1	Clinical Chemistry	No	1979-03-15
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	Class 2	Clinical Chemistry	No	2013-04-09

Proprietary Names

LIAISON Control Toxo IgG ll LIAISON Toxo IgG ll Parvovirus B19 IgM Enzyme Immunoassay LIAISON® XL HCG HUMAN GROWTH HORMONE LIAISON hGH LIAISON hGH control set LIAISON IGF-1 LIAISON® Control Toxo IgM II LIAISON® Toxo IgM II Parvovirus B19 IgG Enzyme Immunoassay LIAISON Anti-HAV LIAISON XL Analyzer Workcell Upgrade Kit ETI-AB-DELTAk2 ETI-AB-AUK-3 Negative Control ETI-AB-AUK-3 LIAISON XL MUREX Anti-HBe LIAISON XL MUREX Control Anti-HBe LIAISON VZV IgG HT LIAISON Control VZV IgG HT LIAISON® diluteX LIAISON Light Check LIAISON Wash/System Liquid LIAISON XL Clean Tool LIAISON Light Check 12 LIAISON Starter kit LIAISON Clean Kit LIAISON XL Starter kit LIAISON Analyzer LIAISON XL Analyzer LIAISON® MUREX Control HIV Ab/Ag HT LIAISON® MUREX HIV Ab/Ag HT LIAISON® Control QuantiFERON®-TB Gold Plus II LIAISON® QuantiFERON®-TB Gold Plus LIAISON® QuantiFERON® Software LIAISON® Control QuantiFERON®-TB Gold Plus LIAISON® QuantiFERON®-TB Gold Plus II LIAISON(R) Treponema Assay LIAISON(R)Treponema Control Set LIAISON® Control Rubella IgM LIAISON® Rubella IgM assay LIAISON Control Direct Renin LIAISON Direct Renin LIAISON FSH LIAISON Control Thyroid 1, LIAISON Control Thyroid 2, LIAISON Control Thyroid 3 LIAISON FT4 LIAISON Control Measles IgG LIAISON Measles IgG S100B ELISA TK-REA LIAISON NSE LIAISON TK LIAISON Rubella IgG LIAISON Rubella IgG Tri-Controls LIAISON BRAHMS PCT II GEN Verifiers LIAISON BRAHMS PCT II GEN LIAISON BRAHMS Control PCT II GEN ETI-EBK PLUS LIAISON Control Ferritin LIAISON Ferritin LIAISON Ferritin Calibration Verifiers LIAISON XL MUREX Control HBc IgM LIAISON XL MUREX HBc IgM LIAISON XL MUREX Control Anti-HBc LIAISON XL MUREX Anti-HBc LIAISON EBNA IgG Serum Control Set LIAISON VCA IgG Serum Control Set LIAISON(R) CMV IgM LIAISON(R) CMV IgG LIAISON(R) Control CMV IgG LIAISON(R) Control CMV IgM ETI-AB-EBK PLUS LIAISON® EBV IgM Serum Control Set LIAISON LH LIAISON XS Analyzer LIAISON Disposable Tips (x0055) LIAISON EASY Starter kit (319300) LIAISON EASY Wash Buffer (319301) LIAISON Cuvettes on tray (X0053) LIAISON EASY System Liquid LIAISON EASY Cleaning Tool (310996) LIAISON XL MUREX Control HBeAg LIAISON XL MUREX HBeAg LIAISON XL MUREX HBsAg Confirmatory Test LIAISON XL MUREX HBsAg Qual LIAISON XL MUREX Control Qual LIAISON® MUREX Anti-HDV control LIAISON® MUREX Anti-HDV LIAISON FT3 LIAISON® Biotrin Parvovirus B19 IgM Plus LIAISON® Biotrin Control Parvovirus B19 IgM Plus LIAISON(R) Control EA IgG LIAISON(R) EA IgG LIAISON XL MUREX Anti-HBs Verifiers LIAISON XL MUREX Anti-HBs LIAISON XL MUREX Control Anti-HBs LIAISON XL LIAISON Anti-HAV Control Set LIAISON XL Operating Software LIAISON® SARS-CoV-2 TrimericS IgG Control Set LIAISON® SARS-CoV-2 TrimericS IgG LIAISON Prolactin xt LIAISON Mumps IgG and LIAISON Mumps Control Set LIAISON(R) Control EBV IgM LIAISON(R) VCA IgG LIAISON(R) EBNA IgG LIAISON(R) EBV IgM LIAISON(R) Control VCA IgG LIAISO(R) Control EBNA IgG LIAISON® Control SARS-CoV-2 Ag LIAISON® SARS-CoV-2 Ag LIAISON® SARS-CoV-2 Sample Inactivation Buffer ETI-MAX 3000TM Analyzer ETI-MAX 3000 (TM) Analyzer Operating Software LIAISON EA IgG Serum Control Set LIAISON MDX LIAISON CMV IgG Serum Control Set LIAISON MUREX HCV Ab LIAISON MUREX Control HCV Ab LIAISON C-Peptid LIAISON Control Anti-HAV LIAISON Biotrin Parvovirus B19 IgG Plus LIAISON Biotrin Control Parvovirus B19 IgG Plus LIAISON Insulin LIAISON Insulin Control Set LIAISON Endocrinology Diluent LIAISON Control HAV IgM LIAISON HAV IgM LIAISON TSH LIAISON® CMV IgM Serum Control Set

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility