Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5100](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5100) → LRM — Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control # LRM · Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control _Immunology · 21 CFR 866.5100 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM ## Overview - **Product Code:** LRM - **Device Name:** Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control - **Regulation:** [21 CFR 866.5100](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5100) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues). ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 29) Showing 20 most recent of 29 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K101319](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K101319.md) | IMMULISA DSDNA ANTIBODY ELISA | Immco Diagnostics, Inc. | Dec 9, 2010 | SESE | | [K083381](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K083381.md) | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | Euroimmun Us, Inc. | Apr 15, 2009 | SESE | | [K062183](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K062183.md) | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | Nov 21, 2006 | SESE | | [K040811](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K040811.md) | VARELISA SSDNA ANTIBODIES, MODEL 14896 | Pharmacia Deutschland GmbH | May 13, 2004 | SESE | | [K001900](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K001900.md) | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | Helix Diagnostics, Inc. | Sep 11, 2000 | SESE | | [K000477](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K000477.md) | MDI DS-DNA TEST | Micro Detect, Inc. | Mar 1, 2000 | SESE | | [K994424](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K994424.md) | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | Diamedix Corp. | Feb 18, 2000 | SESE | | [K993727](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K993727.md) | BINDAZYME ANTI-DSDNA EIA KIT | The Binding Site, Ltd. | Dec 21, 1999 | SESE | | [K984396](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K984396.md) | LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 | Bio-Rad | Dec 18, 1998 | SESE | | [K983422](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K983422.md) | THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET | Zeus Scientific, Inc. | Nov 18, 1998 | SESE | | [K980391](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K980391.md) | SERAQUEST ANTI-DSDNA | Quest Intl., Inc. | Apr 24, 1998 | SESE | | [K974694](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K974694.md) | IS-DSDNA TEST SYSTEM | Diamedix Corp. | Mar 3, 1998 | SESE | | [K962730](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K962730.md) | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | Hycor Biomedical, Inc. | Mar 7, 1997 | SESE | | [K952567](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K952567.md) | AUTOSTATTMII ANTI-DSDNA | Cogent Diagnotics , Ltd. | Mar 4, 1997 | SESE | | [K960182](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K960182.md) | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM | Mardx Diagnostics, Inc. | Mar 20, 1996 | SESE | | [K960091](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K960091.md) | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | Helix Diagnostics, Inc. | Mar 20, 1996 | SESE | | [K954893](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K954893.md) | HYTEC AUTOMIMMUNE KIT (DS-DNA) | Hycor Biomedical, Inc. | Mar 20, 1996 | SESE | | [K953671](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K953671.md) | ORGEN TEC ANTI-DSDNA ELISA ASSAY | Orgentec | Nov 9, 1995 | SESE | | [K952055](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K952055.md) | ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY | American Laboratory Products Co., Ltd. | Jul 18, 1995 | SESE | | [K944334](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM/K944334.md) | VARELISA COMBINED DNA ANTIBODIES EIA | Elias U.S.A., Inc. | Apr 17, 1995 | SESE | ## Top Applicants - Diamedix Corp. — 3 clearances - Elias U.S.A., Inc. — 2 clearances - Helix Diagnostics, Inc. — 2 clearances - Hycor Biomedical, Inc. — 2 clearances - The Binding Site, Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LRM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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