DeviceClearance

Product code QBQ— Microbiology

BacterioScan 216Dx System

Classification name
System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Device class
Class 1
Regulation
21 CFR 866.2560
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code QBQ under 21 CFR 866.2560, via openFDA

Market context for product code QBQ

FDA has cleared 1 device under product code QBQ, all in 2018, filed by 1 applicant company. 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.

Top applicants under product code QBQ

Recent clearances under product code QBQ

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