Data / Medical devices / Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use (PIV): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use (product code PIV, Class 2, 21 CFR 866.4750). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on November 24, 2015, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PIV
- Device class
- 2
- Regulation
- 866.4750
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 3 |
| Italy | 1 |
Makers of Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 2 | November 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| AESKU.DIAGNOSTICS GmbH&Co.KG | WENDELSHEIM Rhineland-Palatinate, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroimmun Us Inc. | Mountain Lakes, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visia Lab SRL | SAN GIOVANNI VALDARNO Arezzo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 24, 2015. 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.