Product code KTL— Immunology
ADP NDNA IFA TEST
- Classification name
- Anti-Dna Indirect Immunofluorescent Solid Phase
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code KTL
FDA has cleared devices under product code KTL between 1979 and 2023, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2020
- 2018
- 2002
- 2001
- 1999
- 1993
- 1990
- 1986
- 1984
- 1983
- 1979
Top applicants under product code KTL
Recent clearances under product code KTL
- K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
- K203599 — Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
- K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit
- K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
- K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
- K011068 — RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
- K013432 — IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
- K990916 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
- K930987 — CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
- K905386 — DISTAT ANTI-DSDNA KIT
- K864275 — ANTI-NDNA ANTIBODY TEST KIT
- K861978 — AUTOFLUOR V
- K842707 — ADP NDNA IFA TEST
- K834349 — ANTI-NATIVE DNA ANTIBODY
- K834140 — ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
- K833984 — ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
- K832031 — ANTI-N DNA ANTIBODY TEST KIT
- K830652 — ANTI N DNA-HCP
- K791354 — CODE QAS 103 ANTI-DNA CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.