Panels › Microbiology › Product code OZZ · Class 2
Bordetella Pertussis Dna Assay System
Regulation 866.3980
1510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OZZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 20, 2025 | K243753 | cobas liat Bordetella panel nucleic acid test Roche Molecular Systems, Inc. | OZZ |
| Dec 19, 2018 | K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack Diasorin Molecular, LLC | OZZ |
| Aug 13, 2018 | K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack Diasorin Molecular, LLC | OZZ |
| Jul 15, 2018 | K181029 | Solana Bordetella Complete Assay Quidel Corporation | OZZ |
| May 2, 2017 | K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit Luminex Corporation | OZZ |
| Mar 31, 2017 | K170284 | Great Basin Bordetella Direct Test Great Basin Scientific, Inc. | OZZ |
| Nov 10, 2015 | K152285 | illumigene Pertussis DNA Amplification Assay Meridian Bioscience, Inc. | OZZ |
| Dec 10, 2014 | K143206 | AmpliVue Bordetella Assay Quidel Corporation | OZZ |
| Mar 25, 2014 | K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA Meridian Bioscience, Inc. | OZZ |
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