Panels › Microbiology › Product code MKZ · Class 1
Dna Probe, Nucleic Acid Amplification, Chlamydia
Regulation 866.3120
0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in MKZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2023 | K230451 | Aptima® Chlamydia trachomatis Assay Hologic, Inc. | MKZ |
| May 20, 2014 | K140446 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | MKZ |
| Jan 24, 2012 | K110923 | COBAS 4800 CT / NG TEST Roche Molecular Systems, Inc. | MKZ |
| Nov 13, 2009 | K091724 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY Becton, Dickinson & CO | MKZ |
| Jun 2, 2009 | K090824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | MKZ |
| Dec 11, 2008 | K081824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY Becton, Dickinson & CO | MKZ |
| Jul 10, 2008 | K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT Abbott Molecular, Inc. | MKZ |
| Apr 16, 2007 | K070174 | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY Roche Diagnostics Corporation | MKZ |
| Jan 22, 2007 | K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 Gen-Probe, Inc. | MKZ |
| Oct 13, 2006 | K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM Gen-Probe, Inc. | MKZ |
| Aug 10, 2006 | K053287 | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS Roche Diagnostics Corp. | MKZ |
| Jul 25, 2006 | K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 Gen-Probe, Inc. | MKZ |
| Jan 27, 2005 | K043072 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS Gen-Probe, Inc. | MKZ |
| Aug 4, 1999 | K973707 | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS Roche Molecular Systems, Inc. | MKZ |
| Dec 15, 1998 | K973718 | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS Roche Molecular Systems, Inc. | MKZ |
| Jun 13, 1997 | K964507 | ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST Roche Molecular Systems, Inc. | MKZ |
| Nov 27, 1996 | K962217 | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT Gen-Probe, Inc. | MKZ |
| Dec 8, 1995 | K934622 | LCX CHLAMYDIA TRACHOMATIS ASSAY Abbott Laboratories | MKZ |
| Jun 15, 1993 | K922906 | AMPLICOR CHLAMYDIA TRACHOMATIS TEST Roche Molecular Systems, Inc. | MKZ |
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