Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615056

FEI Number

1000186023

Entity Name

DIESSE DIAGNOSTICA SENESE S.P.A

City/State/Country

MONTERIGGIONI Siena, IT

Establishment Address

STRADA DEI LAGHI 39, MONTERIGGIONI Siena 53035, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIESSE DIAGNOSTICA SENESE S.P.A (Owner Number: 9038779)

Owner / Operator Contact Address

Viale Decumano, 36, --, MILAN, IT-MI 20157, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH CHORUS ECHINOCOCCUS IgG CHORUS Q FEVER PHASE II IgG CHORUS EVO SANITIZING SOLUTION CHORUS EVO DECONTAMINATION BUFFER CHORUS SANITIZING SOLUTION CHORUS WASHING BUFFER CHORUS NEGATIVE CONTROL/SAMPLE DILUENT CHORUS CLEANING SOLUTION 2000 CHORUS WASHING BUFFER AUTOIMMUNITY CHORUS EVO Chorus ADENOVIRUS IgA CHORUS MUMPS IgG CHORUS POLIOVIRUS IgG Chorus MEASLES IgG CHORUS RESPIRATORY SYNCYTIAL VIRUS IgG CHORUS INFLUENZA B IgG VACU-TEC DOUBLE LABEL (10200/W) VES-TEC (10201/A) VACU-TEC CUVETTE-L (10208) VACU-TEC (10200) VES-TEC CUVETTE-L (10214) VACU-TEC S.C. STERILE (10602) VACU-TEC S.C. (10600) CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS CHORUS TRIO CHORUS TRIO RAS Chorus INFLUENZA A IgG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCB	Antigen, C. Difficile	Microbiology	Class 1	866.2660	2025-08-01
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2008-11-27
GPS	Antigen, Cf, Q Fever	Microbiology	Class 1	866.3500	2008-11-27
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-12-10
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-06-24
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2008-11-27
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	1999-08-18
GOH	Antigens, Cf (Including Cf Control), Poliovirus 1-3	Microbiology	Class 1	866.3405	2008-11-27
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	1999-08-18
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2008-11-27
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2008-11-27
GHC	Tube, Sedimentation Rate	Hematology	Class 1	864.6700	2008-12-01
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2025-08-01
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-11-09
GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Microbiology	Class 1	866.3330	2008-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

Giovanni Lozano Business: DIESSE Inc Email: giovannilozano@us.diesse.it Phone: (470) 7921992

Related Public Records

Same Entity

DIESSE DIAGNOSTICA SENESE S.P.A

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0015-2014	Sekisui Diagnostics LLC	1	Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615056. Last updated year: 2026. Please use registration number 9615056 when referencing this establishment in official correspondence.