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510(k) Data Aggregation
K Number
K070206Device Name
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
Manufacturer
DIAGNOSTIC HYBRIDS, INC.
Date Cleared
2007-08-30
(220 days)
Product Code
GQW, GOW, GQX
Regulation Number
866.3900Why did this record match?
Product Code :
GQW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diagnostic Hybrids, Inc D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decision. Performance testing has not been done on direct patient specimen testing.
Device Description
The Diagnostic Hybrids, Inc. D3 DFA VARICELLA-ZOSTER IDENTIFICATION KIT includes a DFA Reagent that contains a blend of two fluorescein-labeled murine monoclonal antibodies directed against VZV antigens. The kit includes the following components: VZV DFA Reagent, Mounting Fluid, VZV Antigen Control Slides, PBS Concentrate.
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K Number
K990141Device Name
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
Manufacturer
LIGHT DIAGNOSTICS
Date Cleared
1999-10-19
(273 days)
Product Code
GQW, GQN
Regulation Number
866.3900Why did this record match?
Product Code :
GQW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Light Diagnostics SimulFluor™ HSV/VZV Immunofluorescence Assay is a direct immunofluorescence test intended for the simultaneous detection and identification of HSV 1 and 2 and varicella-zoster virus (VZV) from patients with vesicular, oral, genital, or skin lesions, and following amplification of virus in culture. Specimens found to be negative on direct specimen examination should be tested by cell culture.
Device Description
Light Diagnostics SimulFluor™ HSV/VZV Immunofluorescence Assay utilizes a single reagent for the simultaneous detection and identification of HSV and VZV. The primary component, specific for both HSV 1 and 2 will bind to 155kD major capsid protein in HSV-infected cells. The secondary component, specific for VZV, will bind to glycoprotein gp I and the immediate early antigen in VZV-infected cells. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS). Illumination with ultraviolet light allows visualization of the antigen-antibody complexes by fluorescence microscopy. When a FITC filter set is used, the HSV antigen-antibody complex will exhibit an apple green fluorescence and the VZV antigen-antibody complex will fluoresce yellow-gold. Uninfected cells stain a dull red due to the presence of Evans blue in the reagent.
A blend of monoclonal antibodies directed against HSV and VZV is used in the Light Diagnostics SimulFluor™ HSV/VZV reagent. The use of monoclonal antibodies ensures increased specificity of the reagent and reduces the risk of non-specific background or interference.
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K Number
K964872Device Name
VZV ANTIGEN CONTROL SLIDES
Manufacturer
VIRAL ANTIGENS, INC.
Date Cleared
1997-03-18
(103 days)
Product Code
GQW
Regulation Number
866.3900Why did this record match?
Product Code :
GQW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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