Gen-Probe Inc
FDA Regulatory Profile
Gen-Probe Inc appears in FDA public data with 1 recall, 62 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1793-2014, Class III) was initiated on April 17, 2014. Its most recent 510(k) clearance was granted on January 9, 2013.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 62
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1793-2014 | Class III | APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product | April 17, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K122062 | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER | January 9, 2013 |
| K111409 | APTIMA COMBO 2 ASSAY | May 3, 2012 |
| K063664 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 | January 25, 2007 |
| K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | January 22, 2007 |
| K062440 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 | November 7, 2006 |
| K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | October 13, 2006 |
| K061509 | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 | October 4, 2006 |
| K060652 | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY | August 17, 2006 |
| K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | July 25, 2006 |
| K043224 | GEN-PROBE APTIMA COMBO 2 ASSAY | August 9, 2005 |
| K043144 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE | March 14, 2005 |
| K043072 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS | January 27, 2005 |
| K032554 | GEN-PROBE APTIMA COMBO 2 ASSAY | December 31, 2003 |
| K032194 | TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS | December 24, 2003 |
| K022874 | GEN-PROBE APTIMA COMBO 2 ASSAY | September 17, 2002 |
| K003395 | GEN-PROBE APTIMA COMBO 2 ASSAY | May 21, 2001 |
| K962217 | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT | November 27, 1996 |
| K940979 | GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR | October 31, 1994 |
| K920301 | PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY | April 26, 1994 |
| K920302 | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY | April 6, 1994 |