FDA Product Code
FDA Product Code KTL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Zeus Scientific | 2023-08-31 | Traditional | PDF ↗ |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | Immuno Concepts, N.A. , Ltd. | 2023-05-26 | Traditional | PDF ↗ |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Inova Diagnostics, Inc. | 2020-12-11 | Traditional | PDF ↗ |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | 2018-04-20 | Traditional | PDF ↗ |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | 2018-04-20 | Traditional | PDF ↗ |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | Rhigene, Inc. | 2002-04-11 | Traditional | PDF ↗ |
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | Immuno Concepts, Inc. | 2001-11-29 | Traditional | PDF ↗ |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | Stellar Bio Systems, Inc. | 1999-04-21 | Traditional | PDF ↗ |
| K930987 | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) | The Binding Site, Ltd. | 1993-08-10 | Traditional | PDF ↗ |
| K905386 | DISTAT ANTI-DSDNA KIT | Shield Diagnostics, Ltd. | 1990-12-13 | Traditional | PDF ↗ |
| K864275 | ANTI-NDNA ANTIBODY TEST KIT | Cappel Diagnostics, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K861978 | AUTOFLUOR V | Technia Diagnostics , Ltd. | 1986-06-10 | Traditional | PDF ↗ |
| K842707 | ADP NDNA IFA TEST | Apple Diagnostic Products | 1984-08-21 | Traditional | PDF ↗ |
| K834349 | ANTI-NATIVE DNA ANTIBODY | Sigma Chemical Co. | 1984-04-19 | Traditional | PDF ↗ |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Intl. Diagnostic Technology | 1984-01-20 | Traditional | PDF ↗ |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Intl. Diagnostic Technology | 1984-01-04 | Traditional | PDF ↗ |
| K832031 | ANTI-N DNA ANTIBODY TEST KIT | Breit Laboratories, Inc. | 1983-08-11 | Traditional | PDF ↗ |
| K830652 | ANTI N DNA-HCP | Immuno-Products Industries | 1983-03-24 | Traditional | PDF ↗ |
| K791354 | CODE QAS 103 ANTI-DNA CONTROLS | Amersham Corp. | 1979-09-17 | Traditional | PDF ↗ |
Product code KTL · Class II · Immunology. Data: openFDA.