Home › Device types › MKZ
Dna Probe, Nucleic Acid Amplification, Chlamydia
FDA product code MKZ · Class 1 · Microbiology
70
Registered devices
80
Adverse events
3
Recalls
19
510(k) clearances
Devices with this code
cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems — Roche Molecular Systems, Inc.BD Molecular Urine Transport Kit — BECTON, DICKINSON AND COMPANYAptima Combo 2® — Hologic, Inc.cobas® PCR Media Uni Swab Sample Kit — Roche Molecular Systems, Inc.Aptima® — Hologic, Inc.RealTime — ABBOTT MOLECULAR INC.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima Combo 2® — Hologic, Inc.Aptima — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima Combo 2® — Hologic, Inc.Progensa — Hologic, Inc.Visby Medical Power Adapter — Visby Medical, Inc.Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack — Visby Medical, Inc.Alinity m — ABBOTT MOLECULAR INC.Aptima® — Hologic, Inc.BD CTGCTV2 — BECTON, DICKINSON AND COMPANYcobas® 4800 CT/NG Test — Roche Molecular Systems, Inc.RealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.BD CTGCTV2 for BD MAX™ System — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-09-29 | Becton Dickinson & Co. | In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results. |
| 2009-09-18 | Becton Dickinson & Co. | Product was shipped beyond its expiration date. |
| 2004-07-07 | Roche Molecular Systems Inc | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent durin |
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