FDA product code JWZ: Kit, Screening, Trichomonas
JWZ is the FDA product code for kit, screening, trichomonas. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under JWZ, from 8 different applicants. The average 510(k) review took 105 days (median 55). FDA has posted 1 recall for JWZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Screening, Trichomonas |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JWZ clearance
Top JWZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 2 | 1989-08-15 |
| Mercia Diagnostics , Ltd. | 2 | 1989-06-13 |
| California Integrated Diagnostics, Inc. | 2 | 1987-12-07 |
| Genzyme Corp. | 1 | 2004-04-02 |
| Xenotope Diagnostics, Inc. | 1 | 2003-02-20 |
3 more applicants have JWZ clearances. See the full list in Caduvo.
Most recent JWZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033864 | Genzyme Corp. | GENZYME OSOM TRICHOMONAS RAPID TEST | 2004-04-02 | 112 |
| K020595 | Xenotope Diagnostics, Inc. | XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 | 2003-02-20 | 363 |
| K020226 | Hellen Professional Services | XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 | 2002-08-22 | 212 |
| K894246 | Meridian Diagnostics, Inc. | MERIVIEW TM TRICHOMONAS | 1989-08-15 | 55 |
| K892802 | Mercia Diagnostics , Ltd. | SUPER DUO | 1989-06-13 | 57 |
Recalls for JWZ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code JWZ?
JWZ is the FDA product code for kit, screening, trichomonas. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JWZ?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JWZ?
Across 11 cleared submissions the average was 105 days from receipt to decision (median 55).
Which companies have the most JWZ clearances?
Meridian Diagnostics, Inc. (2); Mercia Diagnostics , Ltd. (2); California Integrated Diagnostics, Inc. (2); Genzyme Corp. (1); Xenotope Diagnostics, Inc. (1).
Have JWZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JWZ
- Run a recall and safety report across every JWZ manufacturer
- Watch product code JWZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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