LFY
- Product code
- LFY
- Device name
- Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3900
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 17 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231214 | 2023-10-27 | DiaSorin, Inc. | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT |
Official FDA classification page: LFY
Classification and pathway per current FDA publications. Data from openFDA (CC0).