Product code LRM
- Device name
- Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5100
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101319 | IMMULISA DSDNA ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-12-09 |
| K083381 | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | Euroimmun Us, Inc. | 2009-04-15 |
| K062183 | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 2006-11-21 |
| K040811 | VARELISA SSDNA ANTIBODIES, MODEL 14896 | Pharmacia Deutschland GmbH | 2004-05-13 |
| K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | Helix Diagnostics, Inc. | 2000-09-11 |
| K000477 | MDI DS-DNA TEST | Micro Detect, Inc. | 2000-03-01 |
| K994424 | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | Diamedix Corp. | 2000-02-18 |
| K993727 | BINDAZYME ANTI-DSDNA EIA KIT | The Binding Site, Ltd. | 1999-12-21 |
| K984396 | LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 | Bio-Rad | 1998-12-18 |
| K983422 | THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET | Zeus Scientific, Inc. | 1998-11-18 |
| K980391 | SERAQUEST ANTI-DSDNA | Quest Intl., Inc. | 1998-04-24 |
| K974694 | IS-DSDNA TEST SYSTEM | Diamedix Corp. | 1998-03-03 |
| K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 |
| K952567 | AUTOSTATTMII ANTI-DSDNA | Cogent Diagnotics , Ltd. | 1997-03-04 |
| K954893 | HYTEC AUTOMIMMUNE KIT (DS-DNA) | Hycor Biomedical, Inc. | 1996-03-20 |
| K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | Helix Diagnostics, Inc. | 1996-03-20 |
| K960182 | DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM | Mardx Diagnostics, Inc. | 1996-03-20 |
| K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY | Orgentec | 1995-11-09 |
| K952055 | ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY | American Laboratory Products Co., Ltd. | 1995-07-18 |
| K944334 | VARELISA COMBINED DNA ANTIBODIES EIA | Elias U.S.A., Inc. | 1995-04-17 |
| K950031 | VARELISA DSDNA ANTIBODIES (FARR VERSION) | Elias U.S.A., Inc. | 1995-03-10 |
| K940585 | SELISA ANTI-N DNA ANTIBODIES | Cambridge Life Sciences Plc. | 1994-06-10 |
| K923537 | ENCORE DS-DNA | Clark Laboratories, Inc. | 1992-12-23 |
| K913653 | 3M ANTI-DSDNA FAST TEST | 3M Diagnostic Systems, Inc. | 1991-11-07 |
| K912020 | ANTI-DNA MICROASSAY | Diamedix Corp. | 1991-09-23 |
| K902897 | UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE | United Biotech, Inc. | 1990-07-16 |
| K893036 | ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) | Amersham Corp. | 1989-06-02 |
| K874191 | NDNA ANTIBODY TEST KIT | Lipogen, Inc. | 1987-12-18 |
| K870903 | IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM | Immunomedics, Inc. | 1987-05-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840239035660 | Anti-dsDNA Screen ELISA | DRG International Inc | 2023-08-24 |
| 00840239035653 | Anti-dsDNA IgA ELISA | DRG International Inc | 2023-08-24 |
| 00840239035646 | Anti-dsDNA IgM ELISA | DRG International Inc | 2023-08-24 |
| 00840239034380 | Anti-dsDNA IgG ELISA | DRG International Inc | 2023-08-24 |
| B3507207000 | Gold Standard Diagnostics Is-anti-dsDNA ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-12-02 |
| 00404847434385 | Anti-dsDNA IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 04048474035650 | Anti-dsDNA IgA ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 04048474035643 | Anti-dsDNA IgM ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 04048474034387 | Anti-dsDNA IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 04048474035667 | Anti-dsDNA Screen ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 00404847435641 | Anti-dsDNA IgM ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 00404847435658 | Anti-dsDNA IgA ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 00404847435665 | Anti-dsDNA Screen ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 00845714004247 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002922 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002786 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002960 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 04049016026884 | Anti-dsDNA-NcX ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 05391516743723 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-22 |
| 00845714001888 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-21 |
| 05391516747141 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-19 |
| 00847865012331 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002721 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002448 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865001342 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000093 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000086 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 04260157080683 | ANTI-dsDNA | ORGENTEC Diagnostika GmbH | 2016-08-31 |
| 08426950593478 | QUANTA Lite® HA dsDNA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544111 | QUANTA Lite® dsDNA SC ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |