MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia Class I
FDA product code MKZ covers "Dna Probe, Nucleic Acid Amplification, Chlamydia", a Class I medical device regulated under 21 CFR 866.3120. Submissions are reviewed by the Microbiology panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MKZ
- Device Class
- Class I
- Regulation Number
- 866.3120
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230451 | hologic | Aptima® Chlamydia trachomatis Assay | November 16, 2023 |
| K140446 | becton, dickinson and | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | May 20, 2014 |
| K110923 | roche molecular systems | COBAS 4800 CT / NG TEST | January 24, 2012 |
| K091724 | becton, dickinson and | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | November 13, 2009 |
| K090824 | becton, dickinson and | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | June 2, 2009 |
| K081824 | becton, dickinson and | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | December 11, 2008 |
| K080739 | abbott molecular | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | July 10, 2008 |
| K070174 | roche diagnostics corporation | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCE | April 16, 2007 |
| K063451 | gen-probe | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | January 22, 2007 |
| K061413 | gen-probe | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | October 13, 2006 |
| K053287 | roche diagnostics | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | August 10, 2006 |
| K053446 | gen-probe | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | July 25, 2006 |
| K043072 | gen-probe | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS | January 27, 2005 |
| K973707 | roche molecular systems | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | August 4, 1999 |
| K973718 | roche molecular systems | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | December 15, 1998 |
| K964507 | roche molecular systems | ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST | June 13, 1997 |
| K962217 | gen-probe | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT | November 27, 1996 |
| K934622 | abbott laboratories | LCX CHLAMYDIA TRACHOMATIS ASSAY | December 8, 1995 |
| K922906 | roche molecular systems | AMPLICOR CHLAMYDIA TRACHOMATIS TEST | June 15, 1993 |