Kit, Screening, Trichomonas
FDA product code JWZ · Class I (low risk) · 21 CFR 866.2660 · Microbiology
11510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033864 | Genzyme Osom Trichomonas Rapid TestJWZ · Traditional | Genzyme Corp. | 04/02/2004SE |
| K020595 | Xenostrip-Tv Trichomonas Cassette Test, Model C1383.01JWZ · Traditional | Xenotope Diagnostics, Inc. | 02/20/2003SE |
| K020226 | Xenostrip-Tv Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 &…JWZ · Traditional | Hellen Professional Services | 08/22/2002SE |
| K894246 | Meriview TM TrichomonasJWZ · Traditional | Meridian Diagnostics, Inc. | 08/15/1989SE |
| K892802 | Super DuoJWZ · Traditional | Mercia Diagnostics , Ltd. | 06/13/1989SE |
| K892263 | Merifluor(Tm) -TrichomonasJWZ · Traditional | Meridian Diagnostics, Inc. | 05/24/1989SE |
| K875138 | Trichomate(R) SuperJWZ · Traditional | Mercia Diagnostics , Ltd. | 05/13/1988SE |
| K874259 | Trichomonas Direct Enzyme ImmunoassayJWZ · Traditional | California Integrated Diagnostics, Inc. | 12/07/1987SE |
| K871279 | Modified Trichomonas Direct Specimen Test KitJWZ · Traditional | California Integrated Diagnostics, Inc. | 04/08/1987SE |
| K852665 | Syncor Trich Direct Immunofluorescence AssayJWZ · Traditional | Syncor Intl. Corp. | 08/13/1985SE |
| K830497 | Pem-TJWZ · Traditional | Hedeco | 04/05/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0753-2026 Class II | Trichomonas Vaginalis testDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |