LLM

Test, Antigen, Nuclear, Epstein-Barr Virus

Product code
LLM
Device name
Test, Antigen, Nuclear, Epstein-Barr Virus
Device class
Class 1
21 CFR
21 CFR 866.3235
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)
27 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-07.

NumberDecision dateApplicantDevice nameSummary
K2336052024-08-07Biokit, S.A.ADVIA Centaur EBV-EBNA IgGPDF

1 summaries are archived here for direct download.

Official FDA classification page: LLM
Classification and pathway per current FDA publications. Data from openFDA (CC0).