JWZ · Kit, Screening, Trichomonas
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JWZ |
|---|---|
| Device Name | Kit, Screening, Trichomonas |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST | Genzyme Corp. | Apr 2, 2004 | SESE |
| K020595 | XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 | Xenotope Diagnostics, Inc. | Feb 20, 2003 | SESE |
| K020226 | XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 | Hellen Professional Services | Aug 22, 2002 | SESE |
| K894246 | MERIVIEW TM TRICHOMONAS | Meridian Diagnostics, Inc. | Aug 15, 1989 | SESE |
| K892802 | SUPER DUO | Mercia Diagnostics , Ltd. | Jun 13, 1989 | SESE |
| K892263 | MERIFLUOR(TM) -TRICHOMONAS | Meridian Diagnostics, Inc. | May 24, 1989 | SESE |
| K875138 | TRICHOMATE(R) SUPER | Mercia Diagnostics , Ltd. | May 13, 1988 | SESE |
| K874259 | TRICHOMONAS DIRECT ENZYME IMMUNOASSAY | California Integrated Diagnostics, Inc. | Dec 7, 1987 | SESE |
| K871279 | MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT | California Integrated Diagnostics, Inc. | Apr 8, 1987 | SESE |
| K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY | Syncor Intl. Corp. | Aug 13, 1985 | SESE |
| K830497 | PEM-T | Hedeco | Apr 5, 1983 | SESE |
Top Applicants
- California Integrated Diagnostics, Inc. — 2 clearances
- Mercia Diagnostics , Ltd. — 2 clearances
- Meridian Diagnostics, Inc. — 2 clearances
- Genzyme Corp. — 1 clearance
- Hedeco — 1 clearance
