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System, Test, Systemic Lupus Erythematosus

FDA product code DHC · Class 2 · Immunology

28
Registered devices
0
Adverse events
1
Recalls
16
510(k) clearances

Devices with this code

ASI SLE Slide Test — ARLINGTON SCIENTIFIC, INC.MeDiCa — SCIMEDX CORPORATIONMeDiCa — SCIMEDX CORPORATIONAutoimmune EIA — BIO-RAD LABORATORIES, INC.AccuDiag ™ — Diagnostic Automation, Inc.ASI SLE Slide Test Control Set — ARLINGTON SCIENTIFIC, INC.ASI SLE Slide Test — ARLINGTON SCIENTIFIC, INC.MeDiCa — SCIMEDX CORPORATIONASI SLE Slide Test — ARLINGTON SCIENTIFIC, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Detector Lex SLE — Immunostics Company, IncAutoimmune EIA — BIO-RAD LABORATORIES, INC.MeDiCa — SCIMEDX CORPORATIONASI SLE Slide Test — ARLINGTON SCIENTIFIC, INC.Detector Lex SLE — Immunostics Company, IncMeDiCa — SCIMEDX CORPORATIONCorgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATIONASI SLE Slide Test — ARLINGTON SCIENTIFIC, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATIONASI SLE Slide Test — ARLINGTON SCIENTIFIC, INC.ASI SLE Slide Test — ARLINGTON SCIENTIFIC, INC.

Recent recalls

DateFirmReason
2009-07-14Bio-Rad Laboratories IncThe firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.