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LJM — Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Class II

FDA Device Classification

Classification Details

Product Code
LJM
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
K182353phadiaEliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayNovember 27, 2018
K151559immco diagnosticsImmuLisa Enhanced Centromere Antibody ELISAMarch 11, 2016
K140493phadiaELIA SCL-70S IMMUNOASSAYOctober 30, 2014
K123880inova diagnosticsQUANTA FLASH CENTROMEREFebruary 7, 2014
K131330gold standard diagnosticsGOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KITJanuary 28, 2014
K131185euroimmun usANA SCREEN ELISA (IGG)July 15, 2013
K083188phadia usVARELISA RECOMBI ANA SCREEN, MODEL 12 596March 13, 2009
K050967sweden diagnostics (germany)VARELISA RECOMBI CTD SCREEN, MODEL 13096June 28, 2005
K050625sweden diagnostics (germany)VARELISA RECOMBI ANA PROFILE, MODEL 18496April 26, 2005
K041102immco diagnosticsIMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISAOctober 26, 2004
K040953aeskuAESKULISA ANA HEP-2June 23, 2004
K040810pharmacia deutschlandVARELISA HISTONE ANTIBODIES, MODEL 16496May 14, 2004
K040291theratest laboratoriesEL-ANA PROFILES: ANTI-CHROMATINMarch 11, 2004
K040200rhigeneMESACUP-2 TEST CENP-BMarch 4, 2004
K030929orgentec diagnostikaANA DETECTMay 2, 2003
K024031theratest laboratoriesTHE THERATEST EL-ANA PROFILES: ANTI-CENTROMEREFebruary 6, 2003
K022018rhigeneRHIGENE ANA ELISA TEST SYSTEM, MODEL K7560July 5, 2002
K004019binding siteANA EIA DIAGNOSTIC TEST KITFebruary 15, 2001
K003959inova diagnosticsQUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISAJanuary 22, 2001
K002559theratest laboratoriesEL-ANA PROFILES-2K1September 12, 2000