DeviceClearance

Product code LLM— Microbiology

ADVIA Centaur EBV-EBNA IgG

Classification name
Test, Antigen, Nuclear, Epstein-Barr Virus
Device class
Class 1
Regulation
21 CFR 866.3235
Advisory panel
Microbiology
Total cleared
27
First cleared
Most recent

Market context for product code LLM

FDA has cleared 27 devices under product code LLM between 1984 and 2024, filed by 20 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code LLM

Recent clearances under product code LLM

Data sourced from openFDA. This site is unofficial and independent of the FDA.