PETClass II
Anti-ss-a Ro60 Autoantibodies
Immunology · 21 CFR 866.5100
Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
0 adverse event reports on file
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Event type breakdown
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Most-reported manufacturers
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
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510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.