Product code LKJ
- Device name
- Antinuclear Antibody, 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 |
|---|---|---|---|
| K210902 | EliA Ro52, EliA Ro60 | Phadia AB | 2022-07-27 |
| K113610 | ANA-SCREEN WITH MDSS | Bio-Rad Laboratories | 2012-07-09 |
| K082759 | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY | Phadia US, Inc. | 2009-04-10 |
| K081104 | AESKULISA ANA HEP-2, REF 30-7115US | Aesku Diagnostics | 2008-05-02 |
| K041658 | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 | Bio-Rad Laboratories, Inc. | 2004-12-20 |
| K042416 | ATHENA MULTI-LYTE ANA-II TEST SYSTEM | Zeus Scientific, Inc. | 2004-10-08 |
| K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | Corgenix, Inc. | 2004-01-08 |
| K030775 | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM | Immuno Concepts, N.A. , Ltd. | 2003-05-12 |
| K024218 | LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 | Bio-Rad | 2003-01-17 |
| K024232 | LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 | Bio-Rad | 2003-01-17 |
| K024223 | LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 | Bio-Rad | 2003-01-13 |
| K024226 | LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 | Bio-Rad | 2003-01-10 |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Diagnostic Products Corp. | 2002-06-03 |
| K021103 | MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM | Zeus Scientific, Inc. | 2002-04-24 |
| K011244 | ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM | Zeus Scientific, Inc. | 2001-12-10 |
| K993294 | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | Diamedix Corp. | 1999-10-25 |
| K984478 | LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 | Bio-Rad | 1998-12-22 |
| K984475 | LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 | Bio-Rad | 1998-12-22 |
| K984473 | LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 | Bio-Rad | 1998-12-22 |
| K984470 | LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 | Bio-Rad | 1998-12-22 |
| K984464 | LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 | Bio-Rad | 1998-12-22 |
| K961815 | QUALITROL ANA CONTROL SERUM SET | Consolidated Technologies, Inc. | 1996-09-27 |
| K954891 | HYTEC AUTOIMMUNE KITS (SS-B) | Hycor Biomedical, Inc. | 1995-12-26 |
| K954392 | HYTEC AUTOIMMUNE KIT (SS-A) | Hycor Biomedical, Inc. | 1995-12-26 |
| K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | Helix Diagnostics, Inc. | 1995-12-15 |
| K954700 | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT | Helix Diagnostics, Inc. | 1995-12-15 |
| K932876 | DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT | Shield Diagnostics, Ltd. | 1993-11-15 |
| K931255 | SYNELISA CENP-B ANTIBODIES | Elias U.S.A., Inc. | 1993-09-24 |
| K932302 | SYLNELISA HISTONE ANTIBODIES | Elias U.S.A., Inc. | 1993-08-23 |
| K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT | Biowhittaker Molecular Applications, Inc. | 1993-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B3507207900 | Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit | Gold Standard Diagnostics Corporation | 2025-02-26 |
| 07333066014906 | EliA Ro52 Well | Phadia AB | 2022-09-14 |
| 07333066014876 | EliA Ro60 Well | Phadia AB | 2022-09-14 |
| 07333066015576 | EliA Ro52 Well | Phadia AB | 2022-09-14 |
| 07333066015545 | EliA Ro60 Well | Phadia AB | 2022-09-14 |
| 04250289503501 | AESKULISA® ANA HEp-2 | Aesku.Diagnostics GmbH & Co. KG | 2017-02-28 |
| 00845714004162 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714004179 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714003462 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 00845714004186 | IMMCO DIAGNOSTIC | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 00845714002182 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00840733101014 | ANA Screen ELISA Test Kit | MERIDIAN BIOSCIENCE, INC. | 2016-09-23 |
| 07333066014562 | EliA CENP Well | Phadia AB | 2016-09-23 |
| 07333066014555 | EliA La Well | Phadia AB | 2016-09-23 |
| 07333066014548 | EliA Ro Well | Phadia AB | 2016-09-23 |
| 07333066014531 | EliA Sm Well | Phadia AB | 2016-09-23 |
| 07333066014524 | EliA U1RNP Well | Phadia AB | 2016-09-23 |
| 00845714004315 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00845714004308 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00845714003479 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00845714003318 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00845714001932 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00847865012331 | 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 |
| 03610520310618 | 96AN | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 03610520547663 | ANA PLATE | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 03610520560457 | 96AN | BIO-RAD LABORATORIES, INC. | 2016-09-12 |