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Extractable Antinuclear Antibody, Antigen And Control
FDA product code LLL · Class 2 · Immunology
117
Registered devices
1
Adverse events
4
Recalls
182
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.QUANTA Flash® Ro60 Reagents — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.ENA-6-Profile ELISA — DRG International IncEUROLINE ENA ProfilePlus 4 (IgG) — EUROIMMUN Medizinische Labordiagnostika AGDiamedix — DIAMEDIX CORPORATIONNOVA Gel® SS-A/SS-B “S” Extractable Nuclear Autoantibody Reagents — INOVA DIAGNOSTICS, INC.Trinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.ANA Screen IgG ELISA — DRG International IncQUANTA Lite® TPO ELISA — INOVA DIAGNOSTICS, INC.ENA-6-Profile ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungSeraQuest — QUEST INTERNATIONAL, INC.EliA SymphonyS Well — Phadia ABNOVA Lite® HEp-2 ANA Kit — INOVA DIAGNOSTICS, INC.QUANTA Flash® HMGCR Reagents — INOVA DIAGNOSTICS, INC.QUANTA Lite® Scl-70 ELISA — INOVA DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.Aptiva® CTD Essential Reagent — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Autostat II Anti-SS-B/La — HYCOR BIOMEDICAL LLCQUANTA Lite® ENA 5 ELISA — INOVA DIAGNOSTICS, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-08-06 | Diamedix Corporation | Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. |
| 2011-06-08 | Diamedix Corporation | On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on |
| 2008-11-25 | Immuno Concepts Inc | In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive. |
| 2004-04-20 | Diasorin Inc. | An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing. |
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