FDA device listing
MONOLISA Anti-HAV IgM EIA (EVOLIS)
FDA device listing 1338699494 · Bio-Rad Laboratories (Bio-Rad Services France)
Key facts
| Proprietary names | MONOLISA Anti-HAV IgM EIA (EVOLIS) |
|---|---|
| Owner/operator | Bio-Rad Laboratories (Bio-Rad Services France) |
| Owner/operator number | 10078397 |
| Premarket submissions | K092353 |
| Product codes | JJE, LOL |
| Device names | JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, LOL - Hepatitis A Test (Antibody And Igm Antibody) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.2160, 866.3310 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | Bio-Rad Service France SAS |
| Establishment registrations | 3035708936 |
| FEI numbers | 3035708936 |
| Establishment operations | Foreign Exporter |
| 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