FDA Product Code KTL: Anti-dna Indirect Immunofluorescent Solid Phase
Leading manufacturers include Euroimmun Us, Inc., Intl. Diagnostic Technology and Shield Diagnostics, Ltd..
19
Total
19
Cleared
160d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Anti-dna Indirect Immunofluorescent Solid Phase Devices (Product Code KTL)
19 devices
Cleared
Aug 31, 2023
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
Zeus Scientific
Immunology
90d
Cleared
May 26, 2023
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Immuno Concepts, N.A. , Ltd.
Immunology
898d
Cleared
Dec 11, 2020
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
Inova Diagnostics, Inc.
Immunology
423d
Cleared
Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
Euroimmun Us, Inc.
Immunology
268d
Cleared
Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
Euroimmun Us, Inc.
Immunology
268d
Cleared
Nov 29, 2001
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM
Immuno Concepts, Inc.
Immunology
45d
Cleared
Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
Stellar Bio Systems, Inc.
Immunology
34d
Cleared
Aug 10, 1993
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
The Binding Site, Ltd.
Immunology
166d
Cleared
Dec 13, 1990
DISTAT ANTI-DSDNA KIT
Shield Diagnostics, Ltd.
Immunology
13d
Cleared
Apr 19, 1984
ANTI-NATIVE DNA ANTIBODY
Sigma Chemical Co.
Immunology
128d
Cleared
Jan 20, 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
Intl. Diagnostic Technology
Immunology
51d
Cleared
Jan 04, 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
Intl. Diagnostic Technology
Immunology
48d
Cleared
Sep 17, 1979
CODE QAS 103 ANTI-DNA CONTROLS
Amersham Corp.
Immunology
61d
About Product Code KTL - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code KTL since 1979, with 19 receiving FDA clearance (average review time: 160 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.