Panels › Microbiology › Product code OZX · Class 2
Mycoplasma Pneumoniae Dna Assay System
Regulation 866.3980
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OZX
| Company | 510(k)s | Recalls |
|---|---|---|
| Meridian Bioscience, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2016 | K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 Meridian Bioscience, Inc. | OZX |
| Oct 23, 2015 | K152800 | illumigene Mycoplasma DNA Amplification Assay Meridian Bioscience, Inc. | OZX |
| Jun 5, 2013 | K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT Meridian Bioscience, Inc. | OZX |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.