Home › Device types › LJM
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
FDA product code LJM · Class 2 · Immunology
114
Registered devices
0
Adverse events
2
Recalls
112
510(k) clearances
Devices with this code
Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit — Gold Standard Diagnostics CorporationANA-8-Screen ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungQUANTA Flash® Centromere Reagents — INOVA DIAGNOSTICS, INC.Anti-Jo-1 ELISA — DRG International IncTrinity Biotech — CLARK LABORATORIES, INC.AESKULISA® SS-A — Aesku.Diagnostics GmbH & Co. KGBioPlex 2200 — BIO-RAD LABORATORIES, INC.AESKULISA® snRNP-C — Aesku.Diagnostics GmbH & Co. KGBioPlex 2200 — BIO-RAD LABORATORIES, INC.ImmunoDOT Autoimmunity Panel 1 — GenBioAnti-Scl-70 ELISA — DRG International IncIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.SSB (La) IgG ELISA — DRG International IncSSB (La) IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungANA Detect ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAESKULISA® Cenp-B — Aesku.Diagnostics GmbH & Co. KGReQuest — QUEST INTERNATIONAL, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.ENA-6-Profile ELISA — DRG International IncIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EUROLINE ENA Profile 9 Ag (IgG) — EUROIMMUN Medizinische Labordiagnostika AGTrinity Biotech — CLARK LABORATORIES, INC.SeraQuest — QUEST INTERNATIONAL, INC.DIASTAT ENA Profile — Svar Life Science AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-27 | Calbiotech Inc | The 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 |
| 2008-08-19 | Zeus Scientific Inc | The 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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