Gen-Probe Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
62
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1793-2014Class IIIAPTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. ProductApril 17, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERJanuary 9, 2013
K111409APTIMA COMBO 2 ASSAYMay 3, 2012
K063664GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091January 25, 2007
K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199January 22, 2007
K062440GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091November 7, 2006
K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEMOctober 13, 2006
K061509TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196October 4, 2006
K060652TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAYAugust 17, 2006
K053446GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088July 25, 2006
K043224GEN-PROBE APTIMA COMBO 2 ASSAYAugust 9, 2005
K043144GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAEMarch 14, 2005
K043072GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATISJanuary 27, 2005
K032554GEN-PROBE APTIMA COMBO 2 ASSAYDecember 31, 2003
K032194TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYSDecember 24, 2003
K022874GEN-PROBE APTIMA COMBO 2 ASSAYSeptember 17, 2002
K003395GEN-PROBE APTIMA COMBO 2 ASSAYMay 21, 2001
K962217GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KITNovember 27, 1996
K940979GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORROctober 31, 1994
K920301PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAYApril 26, 1994
K920302PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAYApril 6, 1994