KTL · Anti-Dna Indirect Immunofluorescent Solid Phase
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | KTL |
|---|---|
| Device Name | Anti-Dna Indirect Immunofluorescent Solid Phase |
| Regulation | 21 CFR 866.5100 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Zeus Scientific | Aug 31, 2023 | SESE |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | Immuno Concepts, N.A. , Ltd. | May 26, 2023 | SESE |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Inova Diagnostics, Inc. | Dec 11, 2020 | SESE |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | Apr 20, 2018 | SESE |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Euroimmun Us, Inc. | Apr 20, 2018 | SESE |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | Rhigene, Inc. | Apr 11, 2002 | SESE |
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | Immuno Concepts, Inc. | Nov 29, 2001 | SESE |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | Stellar Bio Systems, Inc. | Apr 21, 1999 | SESE |
| K930987 | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) | The Binding Site, Ltd. | Aug 10, 1993 | SESE |
| K905386 | DISTAT ANTI-DSDNA KIT | Shield Diagnostics, Ltd. | Dec 13, 1990 | SESE |
| K864275 | ANTI-NDNA ANTIBODY TEST KIT | Cappel Diagnostics, Inc. | Dec 15, 1986 | SESE |
| K861978 | AUTOFLUOR V | Technia Diagnostics , Ltd. | Jun 10, 1986 | SESE |
| K842707 | ADP NDNA IFA TEST | Apple Diagnostic Products | Aug 21, 1984 | SESE |
| K834349 | ANTI-NATIVE DNA ANTIBODY | Sigma Chemical Co. | Apr 19, 1984 | SESE |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Intl. Diagnostic Technology | Jan 20, 1984 | SESE |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Intl. Diagnostic Technology | Jan 4, 1984 | SESE |
| K832031 | ANTI-N DNA ANTIBODY TEST KIT | Breit Laboratories, Inc. | Aug 11, 1983 | SESE |
| K830652 | ANTI N DNA-HCP | Immuno-Products Industries | Mar 24, 1983 | SESE |
| K791354 | CODE QAS 103 ANTI-DNA CONTROLS | Amersham Corp. | Sep 17, 1979 | SESE |
Top Applicants
- Euroimmun Us, Inc. — 2 clearances
- Intl. Diagnostic Technology — 2 clearances
- Amersham Corp. — 1 clearance
- Apple Diagnostic Products — 1 clearance
- Breit Laboratories, Inc. — 1 clearance
