LSL

Product Code: LSL


Products Classified as LSL

3455Dna-reagents, NeisseriaNeisseria Spp. Direct Serological Test Reagents.

Total Product Life Cycle (TPLC) Devices

3455Dna-reagents, NeisseriaNeisseria Spp. Direct Serological Test Reagents.

FDA Consensus Standards

Dna-Reagents, Neisseria [33463]21 CFR §866.3390 🔎

Pre-market Notifications for LSL

K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.
K173887Cobas CT/NG For Use On Cobas 6800/8800 SystemsRoche Molecular Systems, Inc.
K173840Xpert CT/NGCepheid
K163184Cobas® CT/NG V2.0 TestRoche Molecular Systems, Inc.
K140887COBAS CT/NG V2.0 TESTROCHE MOLECULAR SYSTEMS, INC.
K140448BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBECTON, DICKINSON & CO.
K140354ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGABBOTT MOLECULAR, INC.
K132270COBAS CT/NG V2.0 TESTROCHE MOLECULAR SYSTEMS, INC.
K132251APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)HOLOGIC / GEN-PROBE INCORPORATED
K121710XPERT CT/NGCEPHEID
K111409APTIMA COMBO 2 ASSAYGEN-PROBE, INC.
K091730BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBECTON, DICKINSON & CO.
K090971BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBECTON, DICKINSON & CO.
K090827BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBECTON, DICKINSON & CO.
K081825BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAYBECTON, DICKINSON & CO.

Global Unique Device Identification Database

00382904428433DNA-REAGENTS, NEISSERIA
00382904428426DNA-REAGENTS, NEISSERIA
00382904411282DNA-REAGENTS, NEISSERIA
00382904411251DNA-REAGENTS, NEISSERIA
00382904411244DNA-REAGENTS, NEISSERIA
30382904411221DNA-REAGENTS, NEISSERIA
00382904410919DNA-REAGENTS, NEISSERIA
00382904407162DNA-REAGENTS, NEISSERIA
00382904407056DNA-REAGENTS, NEISSERIA
00382904407049DNA-REAGENTS, NEISSERIA
00382904404871DNA-REAGENTS, NEISSERIA
00382904404833DNA-REAGENTS, NEISSERIA
00382904404802DNA-REAGENTS, NEISSERIA
00382904404789DNA-REAGENTS, NEISSERIA
30382904404766DNA-REAGENTS, NEISSERIA

Maude Adverse Events

APTIMA COMBO 2HOLOGIC INCORPORATED2020-01-09
APTIMA COMBO 2 ASSAYHOLOGIC INCORPORATED2019-10-14
APTIMA COMBO 2 ASSAYHOLOGIC, INC.2019-09-25
APTIMA COMBO 2 ASSAYHOLOGIC INCORPORATED2019-09-03
APTIMA COMBO 2 ASSAYHOLOGIC, INC.2019-08-07
APTIMA COMBO 2 ASSAYHOLOGIC, INC.2019-08-01
APTIMA COMBO 2 ASSAYHOLOGIC, INC.2019-07-18
APTIMA COMBO 2 ASSAYHOLOGIC INCORPORATED2019-05-30
APTIMA COMBO 2 ASSAYHOLOGIC, INC.2019-05-30
APTIMA COMBO 2 ASSAYHOLOGIC INCORPORATED2019-04-19
APTIMA COMBO 2 ASSAYHOLOGIC INCORPORATED2019-04-19
APTIMA COMBO 2 ASSAYHOLOGIC, INC.2019-04-19
APTIMA COMBO 2 ASSAYHOLOGIC, INC.2019-04-19
APTIMA COMBO 2 ASSAYHOLOGIC, INC2019-03-21
PANTHER INSTRUMENTHOLOGIC INCORPORATED2018-11-14
COBAS PCR MEDIA DUAL SWAB SAMPLE KITROCHE MOLECULAR SYSTEMS, INC.2018-10-15
PANTHER SYSTEMHOLOGIC, INC2018-10-05
PANTHER SYSTEMHOLOGIC, INC.2018-10-05
PANTHER INSTRUMENTHOLOGIC, INC2018-10-01
PANTHER INSTRUMENTHOLOGIC, INC2018-08-22
PANTHER INSTRUMENTHOLOGIC, INC.2018-01-10
PANTHER INSTRUMENTHOLOGIC, INC.2018-01-10
PANTHER INSTRUMENTHOLOGIC INCORPORATED2017-11-29
AC2IN VITRO DIAGNOSTICSHOLOGIC, INC.2017-09-12
KIT, APTIMA CMB2 ASSAYHOLOGIC, INC.2017-09-06
PANTHERHOLOGIC, INC.2017-08-03
KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CEHOLOGIC, INC.2017-06-06
APTIMA MULTITEST COLLECTION TUBESHOLOGIC, INC.2017-05-24
APTIMA MULTITEST COLLECTION TUBESHOLOGIC2017-05-24
APTIMA SPECIMEN COLLECTION DEVICEHOLOGIC, INC.2017-05-18
PROCLEIX ULTRIO ELITE ASSAYHOLOGIC, INC.2017-04-13
PANTHER SYSTEMHOLOGIC, INC2017-03-11
AC2, 250T AMPLIFICATION REAGENTHOLOGIC INCORPORATED2016-10-03
APTIMA COMBO 2 ASSAY ON TIGRIS DTS SYSTEMHOLOGIC, INC.2016-08-03
APTIMA UNISEX COLLECTION KITHOLOGIC, INC.2016-06-13
APTIMA VAGINAL SWAB COLLECTION KITHOLOGIC, INC.2016-05-20
APTIMA SPECIMEN TRANSFER KITHOLOGIC, INC.2016-04-28
APTIMA VAGINAL SWAB SPECIMEN COLLECTION KITHOLOGIC, INC.2016-04-06
APTIMA SPECIMEN COLLECTION KITHOLOGIC INCORPORATED2015-12-15
BD PROBETEC? NEISSERIA GONORRHOEAE (GC) QXBECTON, DICKINSON & CO.2015-10-21
APTIMA SWAB SPECIMEN COLLECTION KITHOLOGIC, INC.2015-10-15
APTIMA VAGINAL SWAB SPECIMEN COLLECTION KITHOLOGIC INC.2015-10-08
APTIMA VAGINAL SWAB SPECIMEN COLLECTION KITHOLOGIC INC.2015-03-04
APTIMA LIQUID PAP TRANSFER TUBESHOLOGIC, INC.2015-01-30
ULTRIO PLUSHOLOGIC INCORPORATED2014-11-26
APTIMA VAGINAL SWAB SPECIMEN COLLECTION KITHOLOGIC, INC.2014-10-29
APTIMA COMBO 2 ASSAYHOLOGIC INCORPORATED2014-10-17
APTIMA COMBO 2 ASSAYGEN-PROBE INCORPORATED2014-02-24
COBAS AMPLICOR CT/NG TESTROCHE MOLECULAR SYSTEMS2013-01-31
COBAS AMPLICOR CT/NG TESTROCHE MOLECULAR SYSTEMS2011-03-22
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