Panels › Microbiology › Product code OQO · Class 2
Herpes Simplex Virus Nucleic Acid Amplification Assay
Regulation 866.3305
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Eragen Biosciences | 2 | 0 |
| Becton, Dickinson & CO | 1 | 0 |
| Biohelix Corporation | 1 | 0 |
| DiaSorin Molecular LLC | 0 | 1 |
| Focus Diagnostics | 1 | 0 |
| Hologic, Inc. | 1 | 0 |
| Intelligent Medical Devices, Inc. | 1 | 0 |
| Qiagen | 1 | 0 |
| Quidel Corporation | 1 | 0 |
| Roche Molecular Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | DiaSorin Molecular LLC MOL2150 Simplexa HSV 1&2 Direct
-CSF
-Genital Swab
-Cutaneous / Mucocutaneous Swabs
Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation o Terminated |
OQO | K141458 K150962 |
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