Product code QQV— Microbiology
BD Kiestra IdentifA
- Classification name
- Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
- Device class
- Class 2
- Regulation
- 21 CFR 866.3378
- Advisory panel
- Microbiology
- Total cleared
- 4
- First cleared
- Most recent
FDA classification definition
“An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).”
Market context for product code QQV
FDA has cleared devices under product code QQV 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
- 2023
- 2021
Top applicants under product code QQV
Adverse events under product code QQV
product code QQV- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code QQV
Data sourced from openFDA. This site is unofficial and independent of the FDA.