Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| QUANTA Lite® β2GPI IgG ELISA | 708665 | INOVA DIAGNOSTICS, INC. | MSV | 08426950451112 |
| QUANTA LITE® B2 GPI IgG ELISA Bulk Pack Kit (Lab Corp) | 708665.10L | INOVA DIAGNOSTICS, INC. | MSV | 08426950594543 |
| QUANTA Lite® β2GPI IgG ELISA Bulk Pack | 708665.10 | INOVA DIAGNOSTICS, INC. | MSV | 08426950595816 |