DeviceClearance

Product code QQY— Microbiology

APAS Independence with IC Chromogenic MRSA BD Analysis Module +1 more

Classification name
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Device class
Class 2
Regulation
21 CFR 866.2190
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.”

— U.S. Food and Drug Administration, device classification record for product code QQY under 21 CFR 866.2190, via openFDA

Market context for product code QQY

FDA has cleared 2 devices under product code QQY between 2021 and 2023, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QQY

Recent clearances under product code QQY

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