Atlas FDA

MKZ

19 FDA 510(k) clearances · Product code

170 daysmedian time to decision
674 days90th percentile
19clearances measured

FDA profile

Official device name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Device class
Class I (low risk)
Regulation
21 CFR 866.3120
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2006: 3 · 2011: 9 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Aptima® Chlamydia trachomatis Assay (K230451)Hologic, Inc.2023-11-16
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K140446)Becton, Dickinson & CO2014-05-20
COBAS 4800 CT / NG TEST (K110923)Roche Molecular Systems, Inc.2012-01-24
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K091724)Becton, Dickinson & CO2009-11-13
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K090824)Becton, Dickinson & CO2009-06-02
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K081824)Becton, Dickinson & CO2008-12-11
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (K080739)Abbott Molecular, Inc.2008-07-10
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY (K070174)Roche Diagnostics Corporation2007-04-16
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (K063451)Gen-Probe, Inc.2007-01-22
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (K061413)Gen-Probe, Inc.2006-10-13
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K053287)Roche Diagnostics Corp.2006-08-10
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (K053446)Gen-Probe, Inc.2006-07-25
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS (K043072)Gen-Probe, Inc.2005-01-27
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973707)Roche Molecular Systems, Inc.1999-08-04
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973718)Roche Molecular Systems, Inc.1998-12-15
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K964507)Roche Molecular Systems, Inc.1997-06-13
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT (K962217)Gen-Probe, Inc.1996-11-27
LCX CHLAMYDIA TRACHOMATIS ASSAY (K934622)Abbott Laboratories1995-12-08
AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K922906)Roche Molecular Systems, Inc.1993-06-15

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Every clearance here is in the API, with alerts when new ones post.