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LRM — Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control Class II

FDA Device Classification

Classification Details

Product Code
LRM
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
K101319immco diagnosticsIMMULISA DSDNA ANTIBODY ELISADecember 9, 2010
K083381euroimmun usEUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)April 15, 2009
K062183binding siteFARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITNovember 21, 2006
K040811pharmacia deutschlandVARELISA SSDNA ANTIBODIES, MODEL 14896May 13, 2004
K001900helix diagnosticsENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTSeptember 11, 2000
K000477micro detectMDI DS-DNA TESTMarch 1, 2000
K994424diamedixDIAMEDIX IS-ANTI-DSDNA TEST SYSTEMFebruary 18, 2000
K993727binding siteBINDAZYME ANTI-DSDNA EIA KITDecember 21, 1999
K984396bio-radLIQUICHEK ANTI-DSDNA CONTROL, MODEL 213December 18, 1998
K983422zeus scientificTHE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNNovember 18, 1998
K980391quest intlSERAQUEST ANTI-DSDNAApril 24, 1998
K974694diamedixIS-DSDNA TEST SYSTEMMarch 3, 1998
K962730hycor biomedicalHYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODYMarch 7, 1997
K952567cogent diagnoticsAUTOSTATTMII ANTI-DSDNAMarch 4, 1997
K954893hycor biomedicalHYTEC AUTOMIMMUNE KIT (DS-DNA)March 20, 1996
K960091helix diagnosticsENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITMarch 20, 1996
K960182mardx diagnosticsDSDNA IMMUNOGLOBULIN EIA TEST SYSTEMMarch 20, 1996
K953671orgentecORGEN TEC ANTI-DSDNA ELISA ASSAYNovember 9, 1995
K952055american laboratory products coORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAYJuly 18, 1995
K944334elias u.s.aVARELISA COMBINED DNA ANTIBODIES EIAApril 17, 1995