LFX
- Product code
- LFX
- Device name
- Enzyme Linked Immunoabsorbent Assay, Rubella
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 94 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250588 | 2025-11-17 | Beckman Coulter, Inc. | Access Rubella IgG | |
| K243168 | 2025-06-20 | Abbott Laboratories | Alinity i Rubella IgG |
Official FDA classification page: LFX
Classification and pathway per current FDA publications. Data from openFDA (CC0).