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Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

FDA product code LJM · Class 2 · Immunology

115
Registered devices
0
Adverse events
2
Recalls
112
510(k) clearances

Devices with this code

AESKULISA® snRNP-C — Aesku.Diagnostics GmbH & Co. KGBioPlex 2200 — BIO-RAD LABORATORIES, INC.Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit — Gold Standard Diagnostics CorporationAnti-Sm ELISA — DRG International IncEUROLINE ENA ProfilePlus 4 (IgG) — EUROIMMUN Medizinische Labordiagnostika AGQUANTA Flash® Centromere Reagents — INOVA DIAGNOSTICS, INC.ENA-6-Profile ELISA — DRG International IncSeraQuest — QUEST INTERNATIONAL, INC.ANTI-RPN/SM — ORGENTEC Diagnostika GmbHSSA (Ro) ELISA — DRG International IncAnti-Scl-70 ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungANA Detect ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTrinity Biotech — CLARK LABORATORIES, INC.Jo-1 IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAnti-RNP/Sm ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungImmunoDOT Serum Control D — GenBioAnti-Centromeres ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGAutoimmune EIA — BIO-RAD LABORATORIES, INC.QUANTA Lite® Centromere ELISA — INOVA DIAGNOSTICS, INC.AESKULISA® Scl-70 — Aesku.Diagnostics GmbH & Co. KGBioPlex 2200 — BIO-RAD LABORATORIES, INC.ReQuest — QUEST INTERNATIONAL, INC.ANTI-JO-1 — ORGENTEC Diagnostika GmbHANA Combi (ANA-8-Profile) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung

Recent recalls

DateFirmReason
2008-08-27Calbiotech IncThe recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential healt
2008-08-19Zeus Scientific IncThe Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV s

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