510(k) clearance for Hycor's autoimmune disease test:
This article was originally published in Clinica
The US FDA has cleared Hycor Biomedical's ANA-ELISA test for detecting the presence of antinuclear bodies associated with autoimmune disease such as systemic lupus erythematosus. The test is designed to allow a large number of samples to be screened in an automated fashion and then followed by further testing of individual positive samples, according to the Garden Grove, California-based company.
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