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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2025 | K250050 | miDiagnostics HSV-1&2 CSF Test Midiagnostics NV, BE | PGH |
| Jul 1, 2014 | K141458 | SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK Focus Diagnostics | PGH |
| Mar 21, 2014 | DEN130049 | SIMPLEXA HSV 1&2 DIRECT Focus Diagnostics | PGH |
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