Product code
QDS: Mers-cov and common respiratory pathogens semi-quantitative and quantitative multiplex nucleic acid detection system
FDA product code · Class II · Microbiology
Key facts
| Product code | QDS |
|---|---|
| Device | Mers-cov and common respiratory pathogens semi-quantitative and quantitative multiplex nucleic acid detection system |
| Device class | Class II |
| Regulation number | 866.4001 |
| Review panel | Microbiology |
| Medical specialty | Pathology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for… |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database