Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
The Culture-Based Short-Term Incubation Antimicrobial Resistance Assay is an in vitro diagnostic device that uses reporter expression to detect and identify live microorganisms and detect associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection. It is classified as FDA Class 2, requiring 510(k) clearance, regulated under 21 CFR 866.1655 within the Microbiology medical specialty. The product code is QIV. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QIV
- Device Class
- FDA class 2
- Regulation Number
- 866.1655
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN190016 | cobas vivoDx MRSA | Dec 05, 2019 | Unknown | Roche Molecular Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.