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LSL — Dna-Reagents, Neisseria Class II

FDA Device Classification

Classification Details

Product Code
LSL
Device Class
Class II
Regulation Number
866.3390
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231329hologicAptima Neisseria gonorrhoeae AssayJanuary 26, 2024
K180681hologicAptima Combo 2 Assay (Panther System)June 13, 2018
K173887roche molecular systemscobas CT/NG for use on cobas 6800/8800 systemsMarch 21, 2018
K173840cepheidXpert CT/NGMarch 16, 2018
K163184roche molecular systemscobas® CT/NG v2.0 TestFebruary 9, 2017
K140448becton, dickinson andBD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYMay 20, 2014
K140354abbott molecularABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGMay 9, 2014
K140887roche molecular systemsCOBAS CT/NG V2.0 TESTMay 5, 2014
K132270roche molecular systemsCOBAS CT/NG V2.0 TESTDecember 2, 2013
K132251hologic / gen-probe incorporatedAPTIMA COMBO 2 ASSAY (PANTHER SYSTEM)October 17, 2013
K121710cepheidXPERT CT/NGDecember 27, 2012
K111409gen-probeAPTIMA COMBO 2 ASSAYMay 3, 2012
K091730becton, dickinson andBD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYNovember 13, 2009
K090971becton, dickinson andBD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYJune 5, 2009
K090827becton, dickinson andBD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYMay 27, 2009
K081825becton, dickinson andBD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAYDecember 11, 2008
K070172roche diagnostics corporationAMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAEApril 17, 2007
K063664gen-probeGEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091January 25, 2007
K062440gen-probeGEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091November 7, 2006
K061509gen-probeTIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196October 4, 2006