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Anti-Sm Antibody, Antigen And Control
FDA product code LKP · Class 2 · Immunology
17
Registered devices
0
Adverse events
1
Recalls
28
510(k) clearances
Devices with this code
EUROLINE ENA ProfilePlus 4 (IgG) — EUROIMMUN Medizinische Labordiagnostika AGAptiva® CTD Essential Reagent — INOVA DIAGNOSTICS, INC.EliA SmDP-S Well — Phadia ABAutoimmune EIA — BIO-RAD LABORATORIES, INC.EUROLINE ENA Profile 9 Ag (IgG) — EUROIMMUN Medizinische Labordiagnostika AGLiquichek — BIO-RAD LABORATORIES, INC.QUANTA Flash® Sm Reagents — INOVA DIAGNOSTICS, INC.SeraQuest — QUEST INTERNATIONAL, INC.ReQuest — QUEST INTERNATIONAL, INC.Autostat II Anti-Sm — HYCOR BIOMEDICAL LLCReQuest — QUEST INTERNATIONAL, INC.EliA SmDP Well — Phadia ABEUROLINE ENA Profile 9 Ag (IgG) — EUROIMMUN Medizinische Labordiagnostika AGDIASTST anti-Sm — Svar Life Science ABAnti-Sm ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGEUROLINE ENA ProfilePlus 4 (IgG) — EUROIMMUN Medizinische Labordiagnostika AGDIASTAT anti-Sm/RNP — Svar Life Science AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-12-28 | Phadia Ab | All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in |
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