GNY

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Antisera, Fluorescent, Adenovirus 1-33

Device class

Class I (low risk)

Regulation

21 CFR 866.3020

Medical specialty

Microbiology

Adverse events (MAUDE)

2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free