Product code KTL
- Device name
- Anti-Dna Indirect Immunofluorescent Solid Phase
- 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 |
|---|---|---|---|
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Zeus Scientific | 2023-08-31 |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | Immuno Concepts, N.A. , Ltd. | 2023-05-26 |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Inova Diagnostics, Inc. | 2020-12-11 |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | 2018-04-20 |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | 2018-04-20 |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | Rhigene, Inc. | 2002-04-11 |
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | Immuno Concepts, Inc. | 2001-11-29 |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | Stellar Bio Systems, Inc. | 1999-04-21 |
| K930987 | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) | The Binding Site, Ltd. | 1993-08-10 |
| K905386 | DISTAT ANTI-DSDNA KIT | Shield Diagnostics, Ltd. | 1990-12-13 |
| K864275 | ANTI-NDNA ANTIBODY TEST KIT | Cappel Diagnostics, Inc. | 1986-12-15 |
| K861978 | AUTOFLUOR V | Technia Diagnostics , Ltd. | 1986-06-10 |
| K842707 | ADP NDNA IFA TEST | Apple Diagnostic Products | 1984-08-21 |
| K834349 | ANTI-NATIVE DNA ANTIBODY | Sigma Chemical Co. | 1984-04-19 |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Intl. Diagnostic Technology | 1984-01-20 |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Intl. Diagnostic Technology | 1984-01-04 |
| K832031 | ANTI-N DNA ANTIBODY TEST KIT | Breit Laboratories, Inc. | 1983-08-11 |
| K830652 | ANTI N DNA-HCP | Immuno-Products Industries | 1983-03-24 |
| K791354 | CODE QAS 103 ANTI-DNA CONTROLS | Amersham Corp. | 1979-09-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08059304340222 | dIFine DNA Classifier | VISIA LAB SRL | 2024-11-08 |
| 04049016137894 | IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2024-09-11 |
| 04049016152989 | IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2023-07-05 |
| 08426951056538 | NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit | INOVA DIAGNOSTICS, INC. | 2021-03-31 |
| 04049016107057 | IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2020-08-28 |
| 04049016107033 | IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-04-26 |
| 04049016107187 | IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-04-26 |
| 04049016107156 | IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-04-26 |
| 04049016107149 | IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-04-26 |
| 04049016107064 | IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-04-26 |
| 04049016107026 | IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-04-26 |
| 00813545025335 | DNA(C.lucilae) 500 Test(L) | SCIMEDX CORPORATION | 2016-09-20 |
| 00813545023096 | DNA(C. luciliae) 50 Test(L) | SCIMEDX CORPORATION | 2016-09-19 |
| 00813545023119 | DNA(C. luciliae) 100 Test(L) | SCIMEDX CORPORATION | 2016-09-19 |
| 00813545020682 | DNA 5 Well Slide Pack | SCIMEDX CORPORATION | 2016-09-16 |
| 00813545020705 | DNA 10 Well Slide | SCIMEDX CORPORATION | 2016-09-16 |
| 00847817016240 | Kallestad | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 07340058410035 | DIASTAT anti-dsDNA | Svar Life Science AB | 2016-08-12 |