Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDIESSE DIAGNOSTICA SENESE SPA
US
Last updated May 25, 2026
What DIESSE DIAGNOSTICA SENESE SPA makes
The company produces in vitro diagnostic (IVD) devices for measuring erythrocyte sedimentation rate (ESR) and detecting specific immunoglobulin G (IgG) antibodies. These include evacuated and non-evacuated ESR tubes, ESR controls, and enzyme immunoassay (EIA) analysers like the MINI-CUBE. It also offers EIA kits for detecting measles, mumps, poliovirus (serotypes PV1-PV3), and adenovirus IgG antibodies, such as CHORUS Q FEVER PHASE II IgG and CHORUS ADENOVIRUS IgG.
The portfolio consists exclusively of Class I medical devices, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to regulatory requirements for in vitro diagnostics under applicable U.S. regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does DIESSE DIAGNOSTICA SENESE SPA manufacture?
DIESSE DIAGNOSTICA SENESE SPA specializes in in vitro diagnostic (IVD) devices. Their portfolio includes devices for measuring erythrocyte sedimentation rate (ESR) such as evacuated and non-evacuated ESR tubes, ESR controls, and analysers like the MINI-CUBE. They also produce enzyme immunoassay (EIA) kits for detecting specific IgG antibodies, including measles, mumps, poliovirus (serotypes PV1-PV3), adenovirus, and other viral markers like Q fever Phase II IgG. These products are designed for laboratory use in diagnosing infections and monitoring immune responses.
Where is DIESSE DIAGNOSTICA SENESE SPA based?
DIESSE DIAGNOSTICA SENESE SPA operates from the United States. Their devices are developed and manufactured there, ensuring compliance with U.S. regulatory standards for in vitro diagnostics.
Are DIESSE DIAGNOSTICA SENESE SPA’s devices listed in any regulatory registries?
Yes, DIESSE DIAGNOSTICA SENESE SPA’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class I IVD devices like those produced by the company, ensuring traceability and regulatory transparency.
How are DIESSE DIAGNOSTICA SENESE SPA’s devices classified under U.S. regulations?
All of DIESSE DIAGNOSTICA SENESE SPA’s devices fall under Class I classification in the U.S. regulatory framework. Class I devices are generally considered low-risk and typically require only general controls to ensure safety and performance, such as proper labeling and manufacturing practices. This classification applies to their ESR tubes, controls, analysers, and EIA kits.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 435036669
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CHORUS Q FEVER PHASE II IgG | 81171 | FDA UDI | Class I | Active |
| Mini-Cube | 10392 | FDA UDI | Class I | Active |
| Vacu-Tec | 10200 | FDA UDI | Class I | Active |
| ESR Control Cube | 10435 | FDA UDI | Class I | Active |
| Ves-Tec Cuvette-L | 10214 | FDA UDI | Class I | Active |
| Chorus Trio | 81200 | FDA UDI | Class I | Active |
| Vacu-Tec Cuvette-L | 10208 | FDA UDI | Class I | Active |
| Vacu-Tec Double Label | 10200/W | EUDAMEDFDA UDI | Class I | Active |
| ESR Control Cube | 10436 | FDA UDI | Class I | Active |
| Ves-Tec | 10201/A | FDA UDI | Class I | Active |
| Vacu-Tec S.c. | 10600 | FDA UDI | Class I | Active |
| CHORUS ADENOVIRUS IgG | 81196 | FDA UDI | Class I | Active |
| CHORUS MUMPS IgG | 81075 | FDA UDI | Class I | Active |
| CHORUS POLIOVIRUS IgG | 81264 | FDA UDI | Class I | Active |
| ESR Control | 10434 | FDA UDI | Class I | Active |
| CHORUS RESPIRATORY SYNCYTIAL VIRUS IgG | 81036 | FDA UDI | Class I | Active |
| CHORUS MEASLES IgG | 81072 | FDA UDI | Class I | Active |
| Chorus Trio Ras | 81220 | FDA UDI | Class I | Active |
| ESR Control | 10430 | FDA UDI | Class I | Active |
| CHORUS ECHINOCOCCUS IgG | 81284 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.