Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Device Code: 3574
Product Code(s):
PQA Definition: A Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Device For The Direct Detection Of Nucleic Acid Sequences From Microorganisms Associated With Vaginitis Or Bacterial Vaginosis. The Device Is Indic
Device Classification Information
| Device Type ID | 3574 |
| Device Name | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| Physical State | In Vitro Device Consisting Of Reagents And Associated Instrumentation For Detection Of Nucleic Acid Sequences From Microorganisms Associated With Vaginitis Or Bacterial Vaginosis. |
| Technical Method | Qualitative In Vitro Diagnostic Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis Or Bacterial Vaginosis. |
| Target Area | In Vitro Diagnostic Device |
| 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 | 866.3975 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQA |
| 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 | 3574 |
| Device | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| Product Code | PQA |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3975 [🔎] |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Becton Dickinson & Co. | II | Oct-31-2018 |
TPLC Last Update: 2019-04-02 20:32:37