Definition: In Vitro Nucleic Acid Amplification Test For The Qualitative Detection Of Ribosomal Rna From Trichomonas Vaginalis As An Aid In The Diagnosis Of Trichomoniasis From Vaginal, Cervical, Urogenital And Gynecological Specimens From Symptomatic Patients
| Device Type ID | 3151 |
| Device Name | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Physical State | May Include Target Capture, Transcription-mediated Amplification, Semi Automated Analyzer |
| Technical Method | Uses Target Capture, Transcription-mediated Amplification And Hybridization Protection Assay Technologies To Stream Line Specimen Processing, Amplify Target RRNA And Detect Amplicon Respectively |
| Target Area | Vaginal, Cervical,endocervical, Urogenital And Gynecological Specimens |
| Regulation Description | Trichomonas Vaginalis Nucleic Acid Assay. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3151 |
| Device | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Product Code | OUY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Trichomonas Vaginalis Nucleic Acid Assay. |
| CFR Regulation Number | 866.3860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON, AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CEPHEID | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |