Data / Medical devices / Italy / Visia Lab SRL
Visia Lab SRL: FDA-registered device maker in SAN GIOVANNI VALDARNO Arezzo, Italy, 3 510(k) clearances
Visia Lab SRL is registered with the FDA (registration 3026753391) in SAN GIOVANNI VALDARNO Arezzo, Italy. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 7, 2025. Registered through 2026. 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
- 3026753391
- Address
- Via Concetto Marchesi 28, SAN GIOVANNI VALDARNO Arezzo, Italy, 52027
- Owner or operator
- VISIA LAB SRL (10085668)
- Roles
- Manufacturer
- First device listed
- July 19, 2022
- Registered through
- 2026
- Brand names listed
- dIFine ANA HEp-2 Classifier, dIFine ANCA Classifier, dIFine Automated Microscope, dIFine DNA Classifier, dIFine M1 with camera, dIFine P15, dIFine P30
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anti-Dna Indirect Immunofluorescent Solid Phase | KTL | 2 | Manufacturer | accessdata.fda.gov |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | 2 | Manufacturer | accessdata.fda.gov |
| Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | PIV | 2 | Manufacturer | accessdata.fda.gov |
| Microscope, Fluorescence/U.V. | IBK | 1 | Manufacturer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Manufacturer | accessdata.fda.gov |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 7, 2025 | K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | MOB | Substantially Equivalent | Zeus Scientific | accessdata.fda.gov |
| August 31, 2023 | K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | KTL | Substantially Equivalent | Zeus Scientific | accessdata.fda.gov |
| April 29, 2022 | K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | DHN | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Station, Pipetting And Diluting, For Clinical Use
- All makers of Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- All makers of Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- All makers of Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- All makers of Microscope, Fluorescence/U.V.
- All makers of Anti-Dna Indirect Immunofluorescent Solid Phase
Updated May 7, 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.