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510(k) Data Aggregation
K Number
K984123Device Name
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1999-01-11
(54 days)
Product Code
LHL, 83L
Regulation Number
866.3300Why did this record match?
Product Code :
LHL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zeus Scientific, Inc. Legionella ELISA test system is and enzyme-linked immunosorbent assay for the manual or automated, qualitative detection of total antibody (IgGligMligA) to Legionella pneumophila Groups 1 - 6 in human serum. This test is for in vitro diagnostic use.
Device Description
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K Number
K970149Device Name
LEGIONELLA ELISA TEST SYSTEM
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1997-06-18
(154 days)
Product Code
LHL
Regulation Number
866.3300Why did this record match?
Product Code :
LHL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zeus Scientific, Inc. Legionella ELISA test system is intended for the quantitative and/or quantitative detection of IgG/A/M-class antibody to Legionella pneumophila Groups 1 - 6 in human serum. The test system is intended to be used as an aid in the diagnosis of Legionella-related infections. This test is for in vitro diagnostic use.
Device Description
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K Number
K963318Device Name
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
Manufacturer
ARMKEL, LLC.
Date Cleared
1997-03-03
(192 days)
Product Code
LHL
Regulation Number
866.3300Why did this record match?
Product Code :
LHL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
for the qualitative detection of total antibodies (IgG and IgM) 10 Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease.
Device Description
The Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) 10 Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease.
The Legionella pneumophila IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgG/IgM antibodies to Legionella. Purified Legionella pneumopilla antigen (serogroups 1, 2, 3, 4, 5, 6) is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG/IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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