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510(k) Data Aggregation
K Number
K021398Device Name
APL IGA ELISA KIT
Manufacturer
Date Cleared
2002-08-27
(117 days)
Product Code
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE APL DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Antiphospholipid Syndrome is a clinical diagnosis supported by finding a positive antiphospholipid ELISA and/or lupus anticoagulant test. Indications for the test include: patients with unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained occlusion of the arterial circulation resulting in stroke, myocardial infarction, or peripheral gangrene. In patients with unexplained venous thrombosis, other disorder should be excluded, such as protein C, S, or antithrombin III deficiency, as well as malignancy or the nephrotic syndrome. The test is also indicated in women with one or more unexplained second or third trimester pregnancy losses or two or more first trimester losses. Finally, patients with unexplained thrombocytopenia as well as other abnormalities said to be associated with the Antiphospholipid Syndrome should be tested.
The APL® IgA ELISA Kit is a semiquantitative enzyme linked immunosorben assay (ELISA) for use as an aid in diagnosing the Antiphospholipid Syndrome (APS) in patients presenting with thrombosis, pregnancy losses and/or thrombocytopenia. It enables measurement of IgA anticardiolpin antibody levels in human serum.
Device Description
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K Number
K984102Device Name
ACL/APS FACS KIT
Manufacturer
Date Cleared
1999-03-18
(121 days)
Product Code
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE APL DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The aCL/aPS®FACS Kit is and assay for the semi-quantitative determination of antiphospholipid (anticardiolipin-aCL and antiphosphatidy/serine-aPS) antibodies to be used in the aid of the diagnosis of the Antiphospholipid Syndrome (APS). APS is defined as a disorder of recurrent thrombosis, pregnancy loss and/or thrombocytopenia with persistent positive antiphospholipid tests.
Device Description
ACL/aPS FACS Kit
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