Data / Medical devices / United Kingdom / DiaSorin Italia S.p.A UK Branch
DiaSorin Italia S.p.A UK Branch: FDA-registered device maker in Dartford Kent, United Kingdom, 2 PMA approvals
DiaSorin Italia S.p.A UK Branch is registered with the FDA (registration 3008576040) in Dartford Kent, United Kingdom. It lists 7 device types. The FDA files 2 PMA approvals under its listings, the newest dated August 29, 2020. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008576040
- Address
- Central Road, Dartford Kent, United Kingdom, DA1 5LR
- Owner or operator
- DiaSorin Inc. (9051149)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 6, 1999
- Registered through
- 2027
- Brand names listed
- LIAISON Analyzer, LIAISON Anti-HAV, LIAISON Clean Kit, LIAISON Cuvettes on tray (X0053), LIAISON Disposable Tips (x0055), LIAISON EASY Cleaning Tool (310996), LIAISON EASY Starter kit (319300), LIAISON EASY System Liquid and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Contract manufacturer | accessdata.fda.gov |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | 1 | Contract manufacturer | accessdata.fda.gov |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | 2 | Manufacturer | accessdata.fda.gov |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | 2 | Contract manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2 | Manufacturer | accessdata.fda.gov |
| Test, Hiv Detection | MZF | 2 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 29, 2020 | P190017 | LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test | LOM | 25 | October 10, 2025 | accessdata.fda.gov |
| October 18, 2019 | P190011 | LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab | MZO | 3 | August 10, 2021 | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Hepatitis A Test (Antibody And Igm Antibody)
- All makers of Analyzer, Chemistry, Micro, For Clinical Use
- All makers of Test, Hiv Detection
- All makers of Reagents, Specific, Analyte
- All makers of Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.