FDA device listing
BioPlex 2200 MMRV IgG
FDA device listing 1368288217 · BIO-RAD LABORATORIES, INC.
Key facts
| Proprietary names | BioPlex 2200 MMRV IgG |
|---|---|
| Owner/operator | BIO-RAD LABORATORIES, INC. |
| Owner/operator number | 3022521 |
| Product codes | LFY, LJB, LJY, OPL |
| Device names | LFY - Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster, LJB - Enzyme Linked Immunoabsorbent Assay, Rubeola Igg, LJY - Enzyme Linked Immunoabsorbent Assay, Mumps Virus, OPL - Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 866.3380, 866.3510, 866.3520, 866.3900 |
| Review panels | Microbiology |
| Registered establishments | BIO-RAD LABORATORIES, INC. |
| Establishment registrations | 3032705 |
| FEI numbers | 3002701146 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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