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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to ß-2 Glycoprotein-I (ß-2 GPI) antibodies in human serum
Uses:
The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-ß-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
This device can be used with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Autostat™II Anti-ß2 Glycoprotein -I IgM ELISA." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing a detailed study report demonstrating device performance against specific acceptance criteria.

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