QIV — Culture-Based Short-Term Incubation Antimicrobial Resistance Assay Class II
FDA product code QIV covers "Culture-Based Short-Term Incubation Antimicrobial Resistance Assay", a Class II medical device regulated under 21 CFR 866.1655. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QIV
- Device Class
- Class II
- Regulation Number
- 866.1655
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN190016 | roche molecular systems | cobas vivoDx MRSA | December 5, 2019 |