Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
QIV is the FDA product code for Culture-Based Short-Term Incubation Antimicrobial Resistance Assay, a class II device type, regulated under 21 CFR 866.1655. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QIV
- Device name
- Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
- 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.
- Regulation
- 21 CFR 866.1655
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QIV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2019 | 1 |
Applicants with the most clearances
Product code QIV| Applicant | Clearances |
|---|---|
| Roche Molecular Systems Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.