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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
181
510(k) clearances
Devices with this code
ENA Screen ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungQUANTA Lite® Histone ELISA — INOVA DIAGNOSTICS, INC.QUANTA Flash® Jo-1 Reagents — INOVA DIAGNOSTICS, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.NOVA Gel® Jo-1 “T” Extractable Nuclear Autoantibody Reagents — INOVA DIAGNOSTICS, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Diamedix — DIAMEDIX CORPORATIONIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Diamedix — DIAMEDIX CORPORATIONQUANTA Lite® Sm ELISA — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit — Gold Standard Diagnostics CorporationAutoimmune EIA — BIO-RAD LABORATORIES, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Diamedix — DIAMEDIX CORPORATIONEUROLINE ENA Profile 9 Ag (IgG) — EUROIMMUN Medizinische Labordiagnostika AGQUANTA Lite® ENA 4 ELISA — INOVA DIAGNOSTICS, INC.QUANTA Flash® ENA7 Reagents — INOVA DIAGNOSTICS, INC.Autostat II Anti-Scl-70 — HYCOR BIOMEDICAL LLCQUANTA Flash® ENA7 Reagents — INOVA DIAGNOSTICS, INC.Anti-Scl-70 ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG
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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