Atlas FDA

KTL

19 FDA 510(k) clearances · Product code

51 daysmedian time to decision
423 days90th percentile
19clearances measured

FDA profile

Official device name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine (K231616)Zeus Scientific2023-08-31
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System (K203599)Immuno Concepts, N.A. , Ltd.2023-05-26
NOVA Lite DAPI dsDNA Crithidia luciliae Kit (K192916)Inova Diagnostics, Inc.2020-12-11
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (K172252)Euroimmun Us, Inc.2018-04-20
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (K172244)Euroimmun Us, Inc.2018-04-20
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (K011068)Rhigene, Inc.2002-04-11
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (K013432)Immuno Concepts, Inc.2001-11-29
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY (K990916)Stellar Bio Systems, Inc.1999-04-21
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) (K930987)The Binding Site, Ltd.1993-08-10
DISTAT ANTI-DSDNA KIT (K905386)Shield Diagnostics, Ltd.1990-12-13
ANTI-NDNA ANTIBODY TEST KIT (K864275)Cappel Diagnostics, Inc.1986-12-15
AUTOFLUOR V (K861978)Technia Diagnostics , Ltd.1986-06-10
ADP NDNA IFA TEST (K842707)Apple Diagnostic Products1984-08-21
ANTI-NATIVE DNA ANTIBODY (K834349)Sigma Chemical Co.1984-04-19
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS (K834140)Intl. Diagnostic Technology1984-01-20
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL (K833984)Intl. Diagnostic Technology1984-01-04
ANTI-N DNA ANTIBODY TEST KIT (K832031)Breit Laboratories, Inc.1983-08-11
ANTI N DNA-HCP (K830652)Immuno-Products Industries1983-03-24
CODE QAS 103 ANTI-DNA CONTROLS (K791354)Amersham Corp.1979-09-17

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Every clearance here is in the API, with alerts when new ones post.