QQY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2190
- Medical specialty
- Microbiology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App (K213280) | Bd Kiestra B.V. | 2023-05-04 |
| APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (K200839) | Clever Culture Systems | 2021-10-28 |
Track QQY automatically
Every clearance here is in the API, with alerts when new ones post.