Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
Device Code: 3585
Product Code(s):
QAA Definition: A Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens Is A Qualitative Test For The Detection Of Coccidioides Spp. Nucleic Acids Directly In Clinical Respiratory Specimens From Patients With Signs And Symptoms Of Coccidioidomyco
Device Classification Information
| Device Type ID | 3585 |
| Device Name | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens |
| Physical State | In Vitro Diagnostic Devices That Consist Of Reagents And Associated Instrumentation For The Detection And Identification Of Coccidioides Spp. Nucleic Acids In Respiratory Specimens. |
| Technical Method | Qualitative In Vitro Diagnostic Assay That Detects And Identifies Coccidioides Spp. Nucleic Acids In Respiratory Specimens. |
| Target Area | Respiratory Clinical Specimens From Patients Suspected Of Coccidioidomycosis |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3376 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAA |
| 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 | 3585 |
| Device | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens |
| Product Code | QAA |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3376 [🔎] |
TPLC Last Update: 2019-04-02 20:32:48