Company ยท US
Gen-Probe, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2013. Name variants (Inc, Corp, punctuation) are merged.
63510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LQF | Dna-Reagents, Mycobacterium Spp. | 15 |
| LSL | Dna-Reagents, Neisseria | 15 |
| MDK | Dna-Probe, Reagents, Streptococcal | 5 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 5 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 4 |
| LSK | Dna-Reagents, Chlamydia | 4 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 |
| MCC | Dna-Probe, Haemophilus Spp. | 2 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 2 |
| GRO | Antisera, Fluorescent, All Types, Hemophilus Spp. | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 |
| JTW | System, Transport, Aerobic | 1 |
| JXA | Kit, Screening, Urine | 1 |
| LQG | Dna-Reagents, Mycoplasma Spp. | 1 |
| LQH | Dna-Reagents, Legionella | 1 |
| LQO | Dna-Reagents, Campylobacter Spp. | 1 |
| MBT | Dna-Probe, Reagent, Histoplasma Capsulatum | 1 |
| MCS | Dna-Probe, Staphylococcus Aureus | 1 |
| MCT | Dna-Probe, Strep Pneumoniae | 1 |
| MDC | Dna-Probe - Blastomyces Dermatitidis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2013 | K122062 | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER Gen-Probe, Inc. | OUY |
| May 3, 2012 | K111409 | APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Apr 19, 2011 | DEN110012 | APTIMA TRICHOMONAS VAGINALIS ASSAY Gen-Probe Incorporated | OUY |
| Jan 25, 2007 | K063664 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 Gen-Probe, Inc. | LSL |
| Jan 22, 2007 | K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 Gen-Probe, Inc. | MKZ |
| Nov 7, 2006 | K062440 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 Gen-Probe, Inc. | LSL |
| Oct 13, 2006 | K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM Gen-Probe, Inc. | MKZ |
| Oct 4, 2006 | K061509 | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 Gen-Probe, Inc. | LSL |
| Aug 17, 2006 | K060652 | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Jul 25, 2006 | K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 Gen-Probe, Inc. | MKZ |
| Aug 9, 2005 | K043224 | GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Mar 14, 2005 | K043144 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE Gen-Probe, Inc. | LSL |
| Jan 27, 2005 | K043072 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS Gen-Probe, Inc. | MKZ |
| Dec 31, 2003 | K032554 | GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Dec 24, 2003 | K032194 | TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS Gen-Probe, Inc. | LSL |
| Sep 17, 2002 | K022874 | GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | JTW |
| May 21, 2001 | K003395 | GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc. | LSL |
| Nov 27, 1996 | K962217 | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT Gen-Probe, Inc. | MKZ |
| Oct 31, 1994 | K940979 | GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR Gen-Probe, Inc. | LSL |
| Apr 26, 1994 | K920301 | PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY Gen-Probe, Inc. | LSL |
| Apr 6, 1994 | K920302 | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY Gen-Probe, Inc. | LSK |
| Mar 11, 1994 | K924715 | GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST Gen-Probe, Inc. | MDK |
| Jul 23, 1992 | K921435 | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE Gen-Probe, Inc. | LQF |
| Apr 29, 1992 | K920378 | PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS Gen-Probe, Inc. | LSK |
| Apr 2, 1992 | K915852 | ACCUPACE GROUP A STREPTOCOCCUS ID TEST Gen-Probe, Inc. | MDK |
| Jan 23, 1991 | K905762 | GEN-PROBE LUMINOMETER-LEADER 450 Gen-Probe, Inc. | JJQ |
| Nov 13, 1990 | K904463 | ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST Gen-Probe, Inc. | LQF |
| Nov 13, 1990 | K904268 | ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. Gen-Probe, Inc. | MDK |
| Oct 4, 1990 | K903911 | GEN-PROBE PAL LUMINOMETER Gen-Probe, Inc. | JJQ |
| Oct 2, 1990 | K904047 | ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. Gen-Probe, Inc. | MDF |
| Oct 2, 1990 | K903556 | ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST Gen-Probe, Inc. | MDE |
| Sep 27, 1990 | K903934 | GEN-PROBE LUMINOMETER-LEADER 50 Gen-Probe, Inc. | JJQ |
| Sep 12, 1990 | K903201 | ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST Gen-Probe, Inc. | MDC |
| Aug 23, 1990 | K897077 | ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE Gen-Probe, Inc. | LQF |
| Aug 23, 1990 | K896494 | ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST Gen-Probe, Inc. | LQF |
| Aug 6, 1990 | K902908 | ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR. Gen-Probe, Inc. | MCT |
| Aug 6, 1990 | K902213 | ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA. Gen-Probe, Inc. | MCS |
| Jun 20, 1990 | K901397 | ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. Gen-Probe, Inc. | MCC |
| May 2, 1990 | K897078 | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE Gen-Probe, Inc. | LQF |
| Apr 16, 1990 | K896492 | ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST Gen-Probe, Inc. | LQF |
| Apr 11, 1990 | K896493 | ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST Gen-Probe, Inc. | LQF |
| Mar 8, 1990 | K897079 | ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE Gen-Probe, Inc. | MCC |
| Feb 1, 1990 | K896859 | ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST Gen-Probe, Inc. | MBT |
| Nov 29, 1989 | K895103 | ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION Gen-Probe, Inc. | GTZ |
| Nov 14, 1989 | K895583 | ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. Gen-Probe, Inc. | LSL |
| Nov 14, 1989 | K894712 | ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION Gen-Probe, Inc. | LQO |
| Nov 14, 1989 | K894711 | ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. Gen-Probe, Inc. | GTZ |
| Sep 15, 1989 | K892216 | GEN-PROBE PACE SYSTEM URINE SCREEN Gen-Probe, Inc. | JXA |
| Mar 13, 1989 | K890089 | RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE Gen-Probe, Inc. | LQF |
| Apr 25, 1988 | K881277 | PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS Gen-Probe, Inc. | LSL |
Newest 50 of 63.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2014 | Gen-Probe Inc APTIMA Urine Collection Kit; Catalog Number
301040, Lots 27231, 27232, 27233, and 27234.
Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with A Terminated |
OIE | K003395 |
| Mar 10, 2011 | Gen-Probe Inc Mycobacterium Tuberculosis Complex Culture Identification Test, 2860. Terminated |
LQF | K896493 |
| Mar 10, 2011 | Gen-Probe Inc Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835. Terminated |
LQF | K921435 |
| Mar 10, 2011 | Gen-Probe Inc Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820. Terminated |
MDK | K974572 |
| Dec 19, 2007 | Gen-Probe Inc Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121 Terminated |
MDK | K974572 |
| Jul 20, 2004 | Gen Probe Inc Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001, Terminated |
NDZ | None listed |