FDA Registration
Active
🇬🇧 United Kingdom
DiaSorin Italia S.p.A UK Branch
Reg #: 3008576040
·
FEI: 3008576040
·
Expires 2026
Products
7
Proprietary Names
27
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- DiaSorin Italia S.p.A UK Branch
- Registration Number
- 3008576040
- FEI Number
- 3008576040
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Central Road
- City
- Dartford Kent
- Country
- GB
Regulatory Submissions
- 510(k) Number
- BK241116
- PMA Number
- P190011
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 protected]
- Phone
- 651 4399710
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 1999-01-06 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2025-12-02 |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | Class 2 | Microbiology | No | 2019-11-01 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2010-06-24 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2020-03-13 |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | Class 2 | Microbiology | No | 2020-03-13 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2020-09-03 |
Proprietary Names
LIAISON® MUREX Control HIV Ab/Ag HT
LIAISON® MUREX HIV Ab/Ag HT
LIAISON MUREX HCV Ab
LIAISON MUREX Control HCV Ab
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 XL MUREX Control HIV Ab/Ag HT
LIAISON XL MUREX HIV Ab/Ag HT
LIAISON XS Analyzer
LIAISON Disposable Tips (x0055)
LIAISON EASY Starter kit (319300)
LIAISON EASY Wash Buffer (319301)
LIAISON Anti-HAV
LIAISON Cuvettes on tray (X0053)
LIAISON EASY System Liquid
LIAISON EASY Cleaning Tool (310996)
LIAISON XL MUREX HBsAg Confirmatory Test
LIAISON XL MUREX HBsAg Qual
LIAISON XL MUREX Control Qual
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)