Product code DHN
- Device name
- Antinuclear Antibody, Indirect Immunofluorescent, 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 |
|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Zeus Scientific, Inc. | 2022-04-29 |
| K172745 | ImmuGlo HEp-2 Elite IFA | Immco Diagnostics, Inc. | 2018-06-05 |
| K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | Aesku Systems GmbH&Co.Kg | 2016-07-28 |
| K160265 | Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | 2016-06-17 |
| K141827 | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | Euroimmun Us, Inc. | 2015-04-17 |
| K150155 | NOVA Lite DAPI ANA Kit | Inova Diagnostics, Inc. | 2015-04-08 |
| K131791 | IFA 40: HEP-20-10 | Euroimmun US | 2014-02-26 |
| K120889 | AESKUSLIDES ANA HEP-2 | Aesku Diagnostics | 2012-10-15 |
| K070763 | EUROIMMUN ANA IFA: HEP-20-10 | Euroimmun Us, LLC | 2007-05-22 |
| K042680 | RHIGENE HEP-ANA TEST SYSTEM | Corgenix, Inc. | 2004-11-19 |
| K024220 | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 | Bio-Rad | 2003-01-17 |
| K024217 | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 | Bio-Rad | 2003-01-15 |
| K024221 | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 | Bio-Rad | 2003-01-15 |
| K024222 | LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 | Bio-Rad | 2003-01-15 |
| K024224 | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 | Bio-Rad | 2003-01-15 |
| K024225 | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 | Bio-Rad | 2003-01-15 |
| K024227 | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 | Bio-Rad | 2003-01-15 |
| K024229 | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 | Bio-Rad | 2003-01-15 |
| K024230 | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 | Bio-Rad | 2003-01-15 |
| K024231 | LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 | Bio-Rad | 2003-01-13 |
| K022800 | VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM | Hyperion, Inc. | 2002-11-25 |
| K013213 | HYPERION VISIQUANT ANA TEST KIT | Hyperion, Inc. | 2002-06-04 |
| K012163 | POLYTITER SYSTEM | Polymedco, Inc. | 2001-08-20 |
| K001556 | HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY | The Binding Site, Ltd. | 2000-08-21 |
| K990915 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY | Stellar Bio Systems, Inc. | 1999-04-21 |
| K984400 | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 | Bio-Rad | 1998-12-18 |
| K983924 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO | Immuno Concepts, Inc. | 1998-12-18 |
| K984397 | LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 | Bio-Rad | 1998-12-18 |
| K984399 | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 | Bio-Rad | 1998-12-18 |
| K984398 | LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 | Bio-Rad | 1998-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04250289504942 | AESKUSLIDES® ANA HEp-2-Gamma | Aesku.Diagnostics GmbH & Co. KG | 2025-05-27 |
| 04250289513487 | AESKUSLIDES® ANA-HEp-2 gamma | Aesku.Diagnostics GmbH & Co. KG | 2025-04-06 |
| 08059304340109 | dIFine Automated Microscope | VISIA LAB SRL | 2022-09-07 |
| 00813545026912 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 00813545026905 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 04049016135739 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-05-17 |
| 04049016135722 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-05-17 |
| 10862534000300 | ANA Test Kit | ANTIBODIES INCORPORATED | 2016-12-20 |
| 10862534000331 | nDNA Test Kit | ANTIBODIES INCORPORATED | 2016-12-20 |
| 10862534000317 | ANA Test Kit | ANTIBODIES INCORPORATED | 2016-12-20 |
| 10862534000324 | ANA Test Kit | ANTIBODIES INCORPORATED | 2016-12-20 |
| 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 |
| 04049016099420 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016099451 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016099444 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016099437 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016099413 | IFA 40: HEp-20-10 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 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 |
| 00845714002182 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 08426950594208 | NOVA Lite® HEp-2 External EB Kits | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595267 | NOVA Lite® HEp-2 External EB Kits | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950621843 | NOVA Lite® DAPI ANA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593904 | NOVA Lite® dsDNA Crithidia Luciliae | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950455882 | NOVA Lite® dsDNA Crithidia Luciliae | INOVA DIAGNOSTICS, INC. | 2016-08-31 |