← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

QQY — Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.2190
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →