Panels › Microbiology › Product code PGH · Class 2
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
Regulation 866.3307
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PGH
| Company | 510(k)s | Recalls |
|---|---|---|
| Focus Diagnostics | 2 | 1 |
| Midiagnostics NV | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2150, MOL1451, MOL1452, MOL1455 Terminated |
PGH | K141458 K150962 |
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