FDA Product Code
FDA Product Code OZZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3980
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243753 | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. | 2025-11-20 | Dual Track | PDF ↗ |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018-12-19 | Special | PDF ↗ |
| K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018-08-13 | Traditional | PDF ↗ |
| K181029 | Solana Bordetella Complete Assay | Quidel Corporation | 2018-07-15 | Traditional | PDF ↗ |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | Luminex Corporation | 2017-05-02 | Traditional | PDF ↗ |
| K170284 | Great Basin Bordetella Direct Test | Great Basin Scientific, Inc. | 2017-03-31 | Traditional | PDF ↗ |
| K152285 | illumigene Pertussis DNA Amplification Assay | Meridian Bioscience, Inc. | 2015-11-10 | Traditional | PDF ↗ |
| K143206 | AmpliVue Bordetella Assay | Quidel Corporation | 2014-12-10 | Traditional | PDF ↗ |
| K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA | Meridian Bioscience, Inc. | 2014-03-25 | Traditional | PDF ↗ |
Product code OZZ · Class II · Microbiology. Data: openFDA.