QBQ

System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

Product code

QBQ

Device name

System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

Device class

Class 1

21 CFR

21 CFR 866.2560

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium

Definition text from the FDA device classification database (U.S. federal government work, public domain).