Gen-Probe, Inc.
Medical device manufacturer in San Diego, CA.
62510(k) clearances
5PMA approvals
5recalls
Device types
- LSL Dna-Reagents, Neisseria 15
- LQF Dna-Reagents, Mycobacterium Spp. 13
- MKZ Dna Probe, Nucleic Acid Amplification… 5
- JJQ Colorimeter, Photometer, Spectrophotometer… 4
- LSK Dna-Reagents, Chlamydia 4
- MDK Dna-Probe, Reagents, Streptococcal 3
- GTZ Antisera, All Groups, Streptococcus Spp. 2
- MCC Dna-Probe, Haemophilus Spp. 2
- OUY Trichomonas Vaginalis Nucleic Acid… 1
- GRO Antisera, Fluorescent, All Types… 1
- MDF Dna-Probe, Reagents, Coccidioides Immitis 1
- MDE Dna-Probe, Reagents, Cryptococcal 1
- MDC Dna-Probe - Blastomyces Dermatitidis 1
- MCT Dna-Probe, Strep Pneumoniae 1
- MCS Dna-Probe, Staphylococcus Aureus 1
- MBT Dna-Probe, Reagent, Histoplasma Capsulatum 1
- LQO Dna-Reagents, Campylobacter Spp. 1
- JXA Kit, Screening, Urine 1
- JTO Discs, Strips And Reagents, Microorganism… 1
- LQH Dna-Reagents, Legionella 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K122062 | Aptima Trichomonas Vaginalis Assay - PantherOUY · Traditional | 01/09/2013SE |
| K111409 | Aptima Combo 2 AssayLSL · Traditional | 05/03/2012SE |
| K063664 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae MODEL#1091LSL · Traditional | 01/25/2007SE |
| K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199MKZ · Traditional | 01/22/2007SE |
| K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091LSL · Traditional | 11/07/2006SE |
| K061413 | Aptima CT Assay on the Tigris DTS SystemMKZ · Traditional | 10/13/2006SE |
| K061509 | Tigris DTS Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196LSL · Traditional | 10/04/2006SE |
| K060652 | Tigris DTS Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 08/17/2006SE |
| K053446 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088MKZ · Traditional | 07/25/2006SE |
| K043224 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 08/09/2005SE |
| K043144 | Gen-Probe Aptima Assay for Neisseria GonorrhoeaeLSL · Traditional | 03/14/2005SE |
| K043072 | Gen-Probe Aptima Assay for Chlamydia TrachomatisMKZ · Traditional | 01/27/2005SE |
| K032554 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 12/31/2003SE |
| K032194 | Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test AssaysLSL · Traditional | 12/24/2003SE |
| K022874 | Gen-Probe Aptima Combo 2 AssayJTW · Traditional | 09/17/2002SE |
| K003395 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 05/21/2001SE |
| K962217 | Gen-Probe Amplified Chlamydia Trachomatis Assay KitMKZ · Traditional | 11/27/1996SE |
| K940979 | Gen-Probe Pace 2C Syst Chlamydia Trac/Neisser GonorrLSL · Traditional | 10/31/1994SE |
| K920301 | Pace 2 Neisseria Gonorrhoeae Probe Confirm. AssayLSL · Traditional | 04/26/1994SE |
| K920302 | Pace 2 Chlamydia Trachomatis Probe Confirm AssayLSK · Traditional | 04/06/1994SE |
| K924715 | Gen-Probe Direct Group a Streptococus TestMDK · Traditional | 03/11/1994SE |
| K921435 | Accuprobe Mycobacterium Avium Complex CultureLQF · Traditional | 07/23/1992SE |
| K920378 | Pace 2 System for Chlamydia TrachomatisLSK · Traditional | 04/29/1992SE |
| K915852 | Accupace Group a Streptococcus Id TestMDK · Traditional | 04/02/1992SE |
| K905762 | Gen-Probe Luminometer-Leader 450JJQ · Traditional | 01/23/1991SE |
| K904463 | Accuprobe Mycobacterium Kansasii Cult Confirm TestLQF · Traditional | 11/13/1990SE |
| K904268 | Accuprobe Streptococcus Pyogenes Culture Confirm.MDK · Traditional | 11/13/1990SE |
| K903911 | Gen-Probe Pal LuminometerJJQ · Traditional | 10/04/1990SE |
| K904047 | Accuprobe Coccidioides Immitis Culture Confirm.MDF · Traditional | 10/02/1990SE |
| K903556 | Accuprobe Cryptococcus Neoformans Culture TestMDE · Traditional | 10/02/1990SE |
| K903934 | Gen-Probe Luminometer-Leader 50JJQ · Traditional | 09/27/1990SE |
| K903201 | Accuprobe Blastomyces Dermatit Cult Confirm TestMDC · Traditional | 09/12/1990SE |
| K897077 | Accuprobe Mycobacterium Intracellulare CultureLQF · Traditional | 08/23/1990SE |
| K896494 | Accuprobe Mycobacterium Avium Culture TestLQF · Traditional | 08/23/1990SE |
| K902908 | Accuprobe Streptococcus Pneumoniae Culture Confir.MCT · Traditional | 08/06/1990SE |
| K902213 | Accuprobe Staphylococcus Aureus Culture Confirma.MCS · Traditional | 08/06/1990SE |
| K901397 | Accuprobe Listeria Monocytogenes Culture Confirma.MCC · Traditional | 06/20/1990SE |
| K897078 | Accuprobe Mycobacterium Avium Complex CultureLQF · Traditional | 05/02/1990SE |
| K896492 | Accuprobe Mycobacterium Gordonae Culture TestLQF · Traditional | 04/16/1990SE |
| K896493 | Accuprobe Mycobacterium Tuberculosis Complex TestLQF · Traditional | 04/11/1990SE |
| K897079 | Accuprobe Haeomphilus Influenzae CultureMCC · Traditional | 03/08/1990SE |
| K896859 | Accuprobe Histoplasma Capsulatum Culture Conf.TestMBT · Traditional | 02/01/1990SE |
| K895103 | Accuprobe Enterococcus Culture ConfirmationGTZ · Traditional | 11/29/1989SE |
| K895583 | Accuprobe Neisseria Gonorrhoeae Culture Confirma.LSL · Traditional | 11/14/1989SE |
| K894712 | Accuprobe Campylobacter Culture ConfirmationLQO · Traditional | 11/14/1989SE |
| K894711 | Accuprobe Group B Streptococcus Culture Confirma.GTZ · Traditional | 11/14/1989SE |
| K892216 | Gen-Probe Pace System Urine ScreenJXA · Traditional | 09/15/1989SE |
| K890089 | Rapid Diag. System for Mycobacterium GordonaeLQF · Traditional | 03/13/1989SE |
| K881277 | Pace System for Neisseria Gonorrhoeae Addi. ClaimsLSL · Traditional | 04/25/1988SE |
| K874620 | Gen-Probe Pace System for Neisseria GonorrhoeaeLSL · Traditional | 03/01/1988SE |
| K874878 | Gen-Probe(R) Pace(Tm) System Chlamydia TrachomatisLSK · Traditional | 12/29/1987SE |
| K871878 | Rapid Diagnostic System for Chlamydia TrachomatisLSK · Traditional | 10/28/1987SE |
| K872219 | Gen-Probe (R) Luminometer - Leader (TM)JJQ · Traditional | 08/21/1987SE |
| K871795 | Rapid Diagnostic System for Mycobacterium Tuber.LQF · Traditional | 07/30/1987SE |
| K870422 | Gen-Probe Beta-Lactamase Test KitJTO · Traditional | 04/21/1987SE |
| K864597 | Gen-Probe Rapid Diagnostic System for MycobacteriaLQF · Traditional | 04/20/1987SE |
| K862614 | Rapid Identi. Test for Mycobacterium TB ComplexLQF · Traditional | 11/10/1986SE |
| K862613 | Rapid Ident. Test for Mycobacterium Avium ComplexLQF · Traditional | 11/10/1986SE |
| K860498 | Gen-Probe Legionella Rapid Diagnostic SystemLQH · Traditional | 07/16/1986SE |
| K860574 | Gen-Probe Mycoplasma Pneumonia Rapid Detect SystemLQG · Traditional | 07/03/1986SE |
| K860782 | Gen-Probe Mycobacterium Rapid Confirmation SystemLQF · Traditional | 07/02/1986SE |
| K851271 | Legionella Culture Confirmatin KitGRO · Traditional | 07/08/1985SE |
PMA approvals
- P120007 Aptima HPV 16 18/45 Genotype Assay · 10/12/2012 · 33 supplements
- P100033 Progensa PCA3 Assay · 02/13/2012 · 12 supplements
- P100042 Aptima HPV Assay · 10/28/2011 · 38 supplements
- P020011 Versant HCV RNA Qualitative Assay · 11/07/2002 · 16 supplements
- P940034 Gen-Probe(R) Amplified Mycobacterium Tuberculosis Direct Test (MTD Test) · 12/15/1995 · 18 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1793-2014 Class III | APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234.…Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The… | 04/17/2014Terminated |
| Z-1438-2011 | Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.This recall has been initiated following the identification of certain assay tubes that do not contain probe… | 12/30/2008Terminated |
| Z-1437-2011 | Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.This recall has been initiated following the identification of certain assay tubes that do not contain probe… | 12/30/2008Terminated |
| Z-1436-2011 | Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.This recall has been initiated following the identification of certain assay tubes that do not contain probe… | 12/30/2008Terminated |
| Z-0145-2008 | Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch…Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus… | 05/02/2007Terminated |