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Gen-Probe, Inc.

62 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (K122062)Gen-Probe, Inc.2013-01-09
APTIMA COMBO 2 ASSAY (K111409)Gen-Probe, Inc.2012-05-03
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (K063664)Gen-Probe, Inc.2007-01-25
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (K063451)Gen-Probe, Inc.2007-01-22
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (K062440)Gen-Probe, Inc.2006-11-07
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (K061413)Gen-Probe, Inc.2006-10-13
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (K061509)Gen-Probe, Inc.2006-10-04
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (K060652)Gen-Probe, Inc.2006-08-17
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (K053446)Gen-Probe, Inc.2006-07-25
GEN-PROBE APTIMA COMBO 2 ASSAY (K043224)Gen-Probe, Inc.2005-08-09
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE (K043144)Gen-Probe, Inc.2005-03-14
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS (K043072)Gen-Probe, Inc.2005-01-27
GEN-PROBE APTIMA COMBO 2 ASSAY (K032554)Gen-Probe, Inc.2003-12-31
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS (K032194)Gen-Probe, Inc.2003-12-24
GEN-PROBE APTIMA COMBO 2 ASSAY (K022874)Gen-Probe, Inc.2002-09-17
GEN-PROBE APTIMA COMBO 2 ASSAY (K003395)Gen-Probe, Inc.2001-05-21
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT (K962217)Gen-Probe, Inc.1996-11-27
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR (K940979)Gen-Probe, Inc.1994-10-31
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY (K920301)Gen-Probe, Inc.1994-04-26
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY (K920302)Gen-Probe, Inc.1994-04-06
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST (K924715)Gen-Probe, Inc.1994-03-11
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K921435)Gen-Probe, Inc.1992-07-23
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS (K920378)Gen-Probe, Inc.1992-04-29
ACCUPACE GROUP A STREPTOCOCCUS ID TEST (K915852)Gen-Probe, Inc.1992-04-02
GEN-PROBE LUMINOMETER-LEADER 450 (K905762)Gen-Probe, Inc.1991-01-23
ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. (K904268)Gen-Probe, Inc.1990-11-13
ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST (K904463)Gen-Probe, Inc.1990-11-13
GEN-PROBE PAL LUMINOMETER (K903911)Gen-Probe, Inc.1990-10-04
ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST (K903556)Gen-Probe, Inc.1990-10-02
ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. (K904047)Gen-Probe, Inc.1990-10-02
GEN-PROBE LUMINOMETER-LEADER 50 (K903934)Gen-Probe, Inc.1990-09-27
ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST (K903201)Gen-Probe, Inc.1990-09-12
ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE (K897077)Gen-Probe, Inc.1990-08-23
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST (K896494)Gen-Probe, Inc.1990-08-23
ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA. (K902213)Gen-Probe, Inc.1990-08-06
ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR. (K902908)Gen-Probe, Inc.1990-08-06
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. (K901397)Gen-Probe, Inc.1990-06-20
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K897078)Gen-Probe, Inc.1990-05-02
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST (K896492)Gen-Probe, Inc.1990-04-16
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST (K896493)Gen-Probe, Inc.1990-04-11
ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE (K897079)Gen-Probe, Inc.1990-03-08
ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST (K896859)Gen-Probe, Inc.1990-02-01
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION (K895103)Gen-Probe, Inc.1989-11-29
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (K894712)Gen-Probe, Inc.1989-11-14
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. (K895583)Gen-Probe, Inc.1989-11-14
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. (K894711)Gen-Probe, Inc.1989-11-14
GEN-PROBE PACE SYSTEM URINE SCREEN (K892216)Gen-Probe, Inc.1989-09-15
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE (K890089)Gen-Probe, Inc.1989-03-13
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS (K881277)Gen-Probe, Inc.1988-04-25
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE (K874620)Gen-Probe, Inc.1988-03-01
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS (K874878)Gen-Probe, Inc.1987-12-29
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (K871878)Gen-Probe, Inc.1987-10-28
GEN-PROBE (R) LUMINOMETER - LEADER (TM) (K872219)Gen-Probe, Inc.1987-08-21
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. (K871795)Gen-Probe, Inc.1987-07-30
GEN-PROBE BETA-LACTAMASE TEST KIT (K870422)Gen-Probe, Inc.1987-04-21
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA (K864597)Gen-Probe, Inc.1987-04-20
RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX (K862613)Gen-Probe, Inc.1986-11-10
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX (K862614)Gen-Probe, Inc.1986-11-10
GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM (K860498)Gen-Probe, Inc.1986-07-16
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM (K860574)Gen-Probe, Inc.1986-07-03
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM (K860782)Gen-Probe, Inc.1986-07-02
LEGIONELLA CULTURE CONFIRMATIN KIT (K851271)Gen-Probe, Inc.1985-07-08

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