Panels › Microbiology › Product code PQZ · Class 1
Gbs Culture Media, Selective And Differential
Regulation 866.2360
0510(k)s in 12 months (4 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in PQZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Hardy Diagnostics | 3 | 1 |
| bioMerieux, Inc. | 1 | 1 |
| Cardinal Health Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751 Open, Classified |
PQZ | K163042 |
| Oct 6, 2020 | Hardy Diagnostics Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 Terminated |
PQZ | K170586 |
| Apr 20, 2020 | Cardinal Health Inc. Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant w Terminated |
PQZ | K170586 |
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