FDA Registration
Active
🇮🇹 Italy
DIESSE DIAGNOSTICA SENESE S.P.A
Reg #: 9615056
·
FEI: 1000186023
·
Expires 2026
Products
17
Proprietary Names
37
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- DIESSE DIAGNOSTICA SENESE S.P.A
- Registration Number
- 9615056
- FEI Number
- 1000186023
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- STRADA DEI LAGHI 39
- City
- MONTERIGGIONI Siena
- Country
- IT
Owner / Operator
- Firm Name
- DIESSE DIAGNOSTICA SENESE S.P.A
- Operator Number
- 9038779
- Address
- Viale Decumano, 36, --
- City
- MILAN
- State
- Milano
- Postal Code
- 20157
- Country
- IT
US Agent
- Business Name
- DIESSE Inc
- Contact Name
- Giovanni Lozano
- Address
- 1139 Fairway Gardens NE
- City
- Atlanta
- State
- GA
- ZIP
- 30319
- Country
- US
- [email protected]
- Phone
- 470 7921992
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigen, C. Difficile | MCB | Class 1 | Microbiology | No | 2025-08-01 |
| Antigen, Agglutinating, Echinococcus Spp. | GPF | Class 1 | Microbiology | No | 2008-11-27 |
| Antigen, Cf, Q Fever | GPS | Class 1 | Microbiology | No | 2008-11-27 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2025-12-10 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2025-06-24 |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | Class 1 | Microbiology | No | 2008-11-27 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 1999-08-18 |
| Antigens, Cf (Including Cf Control), Poliovirus 1-3 | GOH | Class 1 | Microbiology | No | 2008-11-27 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 1999-08-18 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2008-11-27 |
| Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | GNX | Class 1 | Microbiology | No | 2008-11-27 |
| Tube, Sedimentation Rate | GHC | Class 1 | Hematology | No | 2008-12-01 |
| Reagents, Clostridium Difficile Toxin | LLH | Class 1 | Microbiology | No | 2025-08-01 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2023-11-09 |
| P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | JNN | Class 1 | Clinical Chemistry | No | 2024-12-09 |
| Test, Erythrocyte Sedimentation Rate | JPH | Class 1 | Hematology | No | 2003-03-21 |
| Device, Automated Sedimentation Rate | GKB | Class 1 | Hematology | No | 1999-08-20 |
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
CHORUS CLIA FECAL ELASTASE
CHORUS ELASTASE COPROCOLLECT
CHORUS FECAL ELASTASE
ESR Control Cube
ESR Control
CUBE 30 touch
VES MATIC 5
VES MATIC Original
MINI-CUBE
Establishment Types
Manufacture Medical Device