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Anti-Dna Antibody, Antigen And Control

FDA product code LSW · Class 2 · Immunology

11
Registered devices
5
Adverse events
1
Recalls
8
510(k) clearances

Devices with this code

AESKUSLIDES nDNA (Crithidia luciliae) — Aesku.Diagnostics GmbH & Co. KGEliA dsDNA Well — Phadia ABQUANTA Flash® dsDNA Reagents — INOVA DIAGNOSTICS, INC.AESKULISA® dsDNA-G — Aesku.Diagnostics GmbH & Co. KGAESKUSLIDES® nDNA (Crithidia luciliae) — Aesku.Diagnostics GmbH & Co. KGAESKULISA® dsDNA G — Aesku.Diagnostics GmbH & Co. KGAnti-ds-DNA-G ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.AccuDiag ™ — Diagnostic Automation, Inc.Aptiva® CTD Essential Reagent — INOVA DIAGNOSTICS, INC.QUANTA Flash® dsDNA Reagents — INOVA DIAGNOSTICS, INC.AESKULISA® dsDNA-G — Aesku.Diagnostics GmbH & Co. KG

Recent recalls

DateFirmReason
2020-12-14Phadia US IncDecreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient t

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