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KTL — Anti-Dna Indirect Immunofluorescent Solid Phase Class II

FDA Device Classification

Classification Details

Product Code
KTL
Device Class
Class II
Regulation Number
866.5100
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231616zeus scientificZEUS IFA(TM) nDNA Test System, ZEUS dIFineAugust 31, 2023
K203599immuno concepts, n.a.Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent TeMay 26, 2023
K192916inova diagnosticsNOVA Lite DAPI dsDNA Crithidia luciliae KitDecember 11, 2020
K172244euroimmun usEUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternApril 20, 2018
K172252euroimmun usEUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternApril 20, 2018
K011068rhigeneRHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100LApril 11, 2002
K013432immuno conceptsIGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GNovember 29, 2001
K990916stellar bio systemsINDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODYApril 21, 1999
K930987binding siteCRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)August 10, 1993
K905386shield diagnosticsDISTAT ANTI-DSDNA KITDecember 13, 1990
K864275cappel diagnosticsANTI-NDNA ANTIBODY TEST KITDecember 15, 1986
K861978technia diagnosticsAUTOFLUOR VJune 10, 1986
K842707apple diagnostic productsADP NDNA IFA TESTAugust 21, 1984
K834349sigma chemicalANTI-NATIVE DNA ANTIBODYApril 19, 1984
K834140intl. diagnostic technologyANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYSJanuary 20, 1984
K833984intl. diagnostic technologyANTINUCLEAR ANTIBODY IMMUNOLOGICALJanuary 4, 1984
K832031breit laboratoriesANTI-N DNA ANTIBODY TEST KITAugust 11, 1983
K830652immuno-products industriesANTI N DNA-HCPMarch 24, 1983
K791354amershamCODE QAS 103 ANTI-DNA CONTROLSSeptember 17, 1979