FDA Product Code KTL: Anti-dna Indirect Immunofluorescent Solid Phase
Leading manufacturers include Euroimmun Us, Inc., Inova Diagnostics, Inc. and Immuno Concepts, N.A. , 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
Apr 19, 1984
ANTI-NATIVE DNA ANTIBODY
Sigma Chemical Co.
Immunology
128d
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.