QIV
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1655
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| cobas vivoDx MRSA (DEN190016) | Roche Molecular Systems, Inc. | 2019-12-05 |
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