Anti-Dna Indirect Immunofluorescent Solid Phase
The Anti-DNA Indirect Immunofluorescent Solid Phase device is an in vitro diagnostic system used to detect antibodies against double-stranded or single-stranded DNA in patient serum, which is relevant in the diagnosis of autoimmune conditions such as systemic lupus erythematosus. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification prior to marketing. The product code is KTL, regulated under 21 CFR 866.5100, in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- KTL
- Device Class
- FDA class 2
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Aug 31, 2023 | Substantially Equivalent | Zeus Scientific |
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | May 26, 2023 | Substantially Equivalent | Immuno Concepts, N.A. , Ltd. |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Dec 11, 2020 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Apr 20, 2018 | Substantially Equivalent | Euroimmun Us, Inc. |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Apr 20, 2018 | Substantially Equivalent | Euroimmun Us, Inc. |
| K011068 | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | Apr 11, 2002 | Substantially Equivalent | Rhigene, Inc. |
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | Nov 29, 2001 | Substantially Equivalent | Immuno Concepts, Inc. |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | Apr 21, 1999 | Substantially Equivalent | Stellar Bio Systems, Inc. |
| K930987 | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) | Aug 10, 1993 | Substantially Equivalent | The Binding Site, Ltd. |
| K905386 | DISTAT ANTI-DSDNA KIT | Dec 13, 1990 | Substantially Equivalent | Shield Diagnostics, Ltd. |
| K864275 | ANTI-NDNA ANTIBODY TEST KIT | Dec 15, 1986 | Substantially Equivalent | Cappel Diagnostics, Inc. |
| K861978 | AUTOFLUOR V | Jun 10, 1986 | Substantially Equivalent | Technia Diagnostics , Ltd. |
| K842707 | ADP NDNA IFA TEST | Aug 21, 1984 | Substantially Equivalent | Apple Diagnostic Products |
| K834349 | ANTI-NATIVE DNA ANTIBODY | Apr 19, 1984 | Substantially Equivalent | Sigma Chemical Co. |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Jan 20, 1984 | Substantially Equivalent | Intl. Diagnostic Technology |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Jan 04, 1984 | Substantially Equivalent | Intl. Diagnostic Technology |
| K832031 | ANTI-N DNA ANTIBODY TEST KIT | Aug 11, 1983 | Substantially Equivalent | Breit Laboratories, Inc. |
| K830652 | ANTI N DNA-HCP | Mar 24, 1983 | Substantially Equivalent | Immuno-Products Industries |
| K791354 | CODE QAS 103 ANTI-DNA CONTROLS | Sep 17, 1979 | Substantially Equivalent | Amersham Corp. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.