OZZ
9 FDA 510(k) clearances · Product code
90 daysmedian time to decision
350 days90th percentile
9clearances measured
FDA profile
- Official device name
- Bordetella Pertussis Dna Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Medical specialty
- Microbiology
- FDA definition
- A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| cobas liat Bordetella panel nucleic acid test (K243753) | Roche Molecular Systems, Inc. | 2025-11-20 |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K183223) | Diasorin Molecular, LLC | 2018-12-19 |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K173498) | Diasorin Molecular, LLC | 2018-08-13 |
| Solana Bordetella Complete Assay (K181029) | Quidel Corporation | 2018-07-15 |
| ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (K163626) | Luminex Corporation | 2017-05-02 |
| Great Basin Bordetella Direct Test (K170284) | Great Basin Scientific, Inc. | 2017-03-31 |
| illumigene Pertussis DNA Amplification Assay (K152285) | Meridian Bioscience, Inc. | 2015-11-10 |
| AmpliVue Bordetella Assay (K143206) | Quidel Corporation | 2014-12-10 |
| ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA (K133673) | Meridian Bioscience, Inc. | 2014-03-25 |
Track OZZ automatically
Every clearance here is in the API, with alerts when new ones post.