Product code JWZ— Microbiology
GENZYME OSOM TRICHOMONAS RAPID TEST
- Classification name
- Kit, Screening, Trichomonas
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code JWZ
FDA has cleared devices under product code JWZ between 1983 and 2004, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2004
- 2003
- 2002
- 1989
- 1988
- 1987
- 1985
- 1983
Top applicants under product code JWZ
Recent clearances under product code JWZ
- K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST
- K020595 — XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
- K020226 — XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
- K894246 — MERIVIEW TM TRICHOMONAS
- K892802 — SUPER DUO
- K892263 — MERIFLUOR(TM) -TRICHOMONAS
- K875138 — TRICHOMATE(R) SUPER
- K874259 — TRICHOMONAS DIRECT ENZYME IMMUNOASSAY
- K871279 — MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT
- K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
- K830497 — PEM-T
Data sourced from openFDA. This site is unofficial and independent of the FDA.