FDA device listing
AESKUSLIDES ® ANA HEp-2-Gamma; HELIOS® AUTOMATED IFA SYSTEM (IOS-1000)
FDA device listing 1053034119 · PHADIA AB
Key facts
| Proprietary names | AESKUSLIDES ® ANA HEp-2-Gamma; HELIOS® AUTOMATED IFA SYSTEM (IOS-1000) |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Premarket submissions | K153117 |
| Product codes | DHN, PIV |
| Device names | DHN - Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, PIV - Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.4750, 866.5100 |
| Review panels | Immunology |
| Registered establishments | PHADIA US INC. |
| Establishment registrations | 3004973408 |
| FEI numbers | 3004973408 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database