Product code
LJB: Enzyme linked immunoabsorbent assay, rubeola igg
FDA product code · Class I · Microbiology
Key facts
| Product code | LJB |
|---|---|
| Device | Enzyme linked immunoabsorbent assay, rubeola igg |
| Device class | Class I |
| Regulation number | 866.3520 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The qualitative detection of measles specific IgG antibodies in serum or plasma. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database