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510(k) Data Aggregation
K Number
K033864Device Name
GENZYME OSOM TRICHOMONAS RAPID TEST
Manufacturer
GENZYME CORP.
Date Cleared
2004-04-02
(112 days)
Product Code
JWZ
Regulation Number
866.2660Why did this record match?
Product Code :
JWZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs and from the saline solution prepared when making wet mounts from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen. This device is intended for use in physicians' offices as well as clinical laboratories.
Device Description
The OSOM Trichomonas Rapid Test uses color immunochromatographic, capillary flow, "dipstick" technology with antibodies coated on a nitrocellulose membrane. The test procedure requires the solubilization of Trichomonas proteins from a vaginal swab by placing it in a Sample Buffer. The OSOM Trichomonas Rapid Test is then placed in the Sample Buffer, and the mixture migrates along the membrane surface. If Trichomonas is present in the sample, it will form a complex with the primary anti-Trichomonas antibody conjugated to colored particles (blue). The complex will then be bound by the second anti-Trichomonas capture antibody. The appearance of a visible blue test line together with the red control line indicates a positive result.
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K Number
K020595Device Name
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
Manufacturer
XENOTOPE DIAGNOSTICS, INC.
Date Cleared
2003-02-20
(363 days)
Product Code
JWZ
Regulation Number
866.2660Why did this record match?
Product Code :
JWZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xenotope Diagnostics' Inc. XenoStrip™-Tv Trichomonas Cassette Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen.
Device Description
Not Found
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K Number
K020226Device Name
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
Manufacturer
HELLEN PROFESSIONAL SERVICES
Date Cleared
2002-08-22
(212 days)
Product Code
JWZ
Regulation Number
866.2660Why did this record match?
Product Code :
JWZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xenotope Diagnostics Inc. XenoStrip™-Tv Trichomonas Test is Intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. Early detection and treatment of trichomonas-related diseases (vaginitis, trichomoniasis) is useful in the prevention and reduction of disease and disease symptomology.
Device Description
Not Found
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