Respiratory Panel
Device Code: 3593
Product Code(s):
QDP Definition: The Panel Is A Multiplexed Nucleic Acid Test Intended For Use With Systems For The Simultaneous Detection And Identification Of Multiple Respiratory Viral And Bacterial Nucleic Acids, As Well As Select Antimicrobial Resistance Genes, In Sputum-like S
Device Classification Information
| Device Type ID | 3593 |
| Device Name | Respiratory Panel |
| Physical State | Multiplex Nucleic Acid Panel |
| Technical Method | Semi-quantitative Multiplexed Nucleic Acid Test |
| Target Area | Human Clinical Samples |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3985 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3593 |
| Device | Respiratory Panel |
| Product Code | QDP |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3985 [🔎] |
TPLC Last Update: 2019-04-02 20:32:54