Dna Probe, Nucleic Acid Amplification, Chlamydia
FDA product code MKZ · Class I (low risk) · 21 CFR 866.3120 · Microbiology
19510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230451 | Aptima® Chlamydia trachomatis AssayMKZ · Traditional | Hologic, Inc. | 11/16/2023SE |
| K140446 | BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA AssayMKZ · Traditional | Becton, Dickinson & CO | 05/20/2014SE |
| K110923 | Cobas 4800 CT / NG TestMKZ · Traditional | Roche Molecular Systems, Inc. | 01/24/2012SE |
| K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified DNA AssayMKZ · Traditional | Becton, Dickinson & CO | 11/13/2009SE |
| K090824 | BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA AssayMKZ · Traditional | Becton, Dickinson & CO | 06/02/2009SE |
| K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified DNA AssayMKZ · Traditional | Becton, Dickinson & CO | 12/11/2008SE |
| K080739 | Abbott Realtime Ct/Ng Assay and Multi-Collect Specimen Collection KitMKZ · Traditional | Abbott Molecular, Inc. | 07/10/2008SE |
| K070174 | Amplicor Ct/Ng Test for Chlamydia Trachomatis; Roche Scripts for Ct/Ng Test AccessoryMKZ · Traditional | Roche Diagnostics Corporation | 04/16/2007SE |
| K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199MKZ · Traditional | Gen-Probe, Inc. | 01/22/2007SE |
| K061413 | Aptima CT Assay on the Tigris DTS SystemMKZ · Traditional | Gen-Probe, Inc. | 10/13/2006SE |
| K053287 | Cobas Amplicor Ct/Ng Test for Chlamydia TrachomatisMKZ · Traditional | Roche Diagnostics Corp. | 08/10/2006SE |
| K053446 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088MKZ · Traditional | Gen-Probe, Inc. | 07/25/2006SE |
| K043072 | Gen-Probe Aptima Assay for Chlamydia TrachomatisMKZ · Traditional | Gen-Probe, Inc. | 01/27/2005SE |
| K973707 | Roche Amplicor Ct/Ng Test for Chlamydia TrachomatisMKZ · Traditional | Roche Molecular Systems, Inc. | 08/04/1999SE |
| K973718 | Roche Cobas Amplicor Ct/Ng Test for Chlamydia TrachomatisMKZ · Traditional | Roche Molecular Systems, Inc. | 12/15/1998SE |
| K964507 | Roche Cobas Amplicor Chlamydia Trachomatis TestMKZ · Traditional | Roche Molecular Systems, Inc. | 06/13/1997SE |
| K962217 | Gen-Probe Amplified Chlamydia Trachomatis Assay KitMKZ · Traditional | Gen-Probe, Inc. | 11/27/1996SE |
| K934622 | LCX Chlamydia Trachomatis AssayMKZ · Traditional | Abbott Laboratories | 12/08/1995SE |
| K922906 | Amplicor Chlamydia Trachomatis TestMKZ · Traditional | Roche Molecular Systems, Inc. | 06/15/1993SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2658-2011 | BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson…In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or… | Becton Dickinson & Co. | 09/29/2010Terminated |
| Z-0969-2010 | BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink…Product was shipped beyond its expiration date. | Becton Dickinson & Co. | 09/18/2009Terminated |