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Dna-Reagents, Neisseria

FDA product code LSL · 42 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.3390
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1987-12-21 – 2024-01-26

LSL 2024-01-26

Aptima Neisseria gonorrhoeae Assay

Applicant Hologic, Inc.

K number K231329

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LSL 2018-06-13

Aptima Combo 2 Assay (Panther System)

Applicant Hologic, Inc.

K number K180681

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LSL 2018-03-21

cobas CT/NG for use on cobas 6800/8800 systems

Applicant Roche Molecular Systems, Inc.

K number K173887

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LSL 2018-03-16

Xpert CT/NG

Applicant Cepheid

K number K173840

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LSL 2017-02-09

cobas® CT/NG v2.0 Test

Applicant Roche Molecular Systems, Inc.

K number K163184

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LSL 2013-12-02

COBAS CT/NG V2.0 TEST

Applicant Roche Molecular Systems, Inc.

K number K132270

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LSL 2013-10-17

APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)

Applicant Hologic / Gen-Probe Incorporated

K number K132251

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LSL 2012-12-27

XPERT CT/NG

Applicant Cepheid

K number K121710

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LSL 2012-05-03

APTIMA COMBO 2 ASSAY

Applicant Gen-Probe, Inc.

K number K111409

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LSL 2009-11-13

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

Applicant Becton, Dickinson & CO

K number K091730

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LSL 2009-06-05

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

Applicant Becton, Dickinson & CO

K number K090971

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LSL 2009-05-27

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

Applicant Becton, Dickinson & CO

K number K090827

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LSL 2008-12-11

BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY

Applicant Becton, Dickinson & CO

K number K081825

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LSL 2007-04-17

AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

Applicant Roche Diagnostics Corporation

K number K070172

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LSL 2007-01-25

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091

Applicant Gen-Probe, Inc.

K number K063664

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LSL 2006-11-07

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091

Applicant Gen-Probe, Inc.

K number K062440

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LSL 2006-10-04

TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196

Applicant Gen-Probe, Inc.

K number K061509

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LSL 2006-08-17

TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY

Applicant Gen-Probe, Inc.

K number K060652

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LSL 2006-08-10

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

Applicant Roche Diagnostics Corp.

K number K053289

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LSL 2005-11-28

BD VIPER SYSTEM

Applicant Becton, Dickinson & CO

K number K052481

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LSL 2005-09-12

BD PROBE TEC URINE PRESERVATIVE TRANSPORT

Applicant Becton, Dickinson & CO

K number K052224

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LSL 2005-08-09

GEN-PROBE APTIMA COMBO 2 ASSAY

Applicant Gen-Probe, Inc.

K number K043224

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LSL 2005-03-14

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE

Applicant Gen-Probe, Inc.

K number K043144

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LSL 2003-12-31

GEN-PROBE APTIMA COMBO 2 ASSAY

Applicant Gen-Probe, Inc.

K number K032554

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LSL 2003-12-24

TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

Applicant Gen-Probe, Inc.

K number K032194

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LSL 2001-09-24

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

Applicant Digene Corp.

K number K010893

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LSL 2001-09-18

BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY

Applicant Becton, Dickinson & CO

K number K012351

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LSL 2001-05-21

GEN-PROBE APTIMA COMBO 2 ASSAY

Applicant Gen-Probe, Inc.

K number K003395

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LSL 2000-02-29

HYBRID CAPTURE II CT/GC TEST

Applicant Digene Corp.

K number K981567

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LSL 1999-12-01

ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

Applicant Roche Molecular Systems, Inc.

K number K974503

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LSL 1999-11-29

HYBRID CAPTURE II GC-ID

Applicant Digene Corp.

K number K981485

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LSL 1999-11-04

BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY

Applicant Becton Dickinson Microbiology Systems

K number K984631

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LSL 1999-08-11

GONOSTAT GONOCOCCAL DETECTION KIT

Applicant Sierra Diagnostics

K number K991268

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LSL 1999-05-28

ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

Applicant Roche Molecular Systems, Inc.

K number K974342

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LSL 1996-05-06

LCX NEISSERIA GONORRHOEAE ASSAY

Applicant Abbott Laboratories

K number K935833

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LSL 1994-10-31

GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR

Applicant Gen-Probe, Inc.

K number K940979

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LSL 1994-04-26

PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY

Applicant Gen-Probe, Inc.

K number K920301

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LSL 1989-11-14

ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.

Applicant Gen-Probe, Inc.

K number K895583

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LSL 1989-08-15

GONOSTAT

Applicant Technology Management & Marketing, Inc.

K number K883486

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LSL 1988-04-25

PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS

Applicant Gen-Probe, Inc.

K number K881277

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LSL 1988-03-01

GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE

Applicant Gen-Probe, Inc.

K number K874620

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LSL 1987-12-21

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K872628

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