Panels › Microbiology › Product code PGX · Class 2
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Regulation 866.2680
2510(k)s in 12 months (15 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in PGX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 2 | 2 |
| Quidel Corporation | 4 | 0 |
| Alere Scarborough, Inc. | 2 | 0 |
| Focus Diagnostics, Inc. | 1 | 1 |
| Luminex Corporation | 1 | 1 |
| Diasorin Molecular, LLC | 1 | 0 |
| Genepoc, Inc. | 1 | 0 |
| Iquum, Inc. | 1 | 0 |
| Mesa Biotech, Inc. | 1 | 0 |
| Roche Molecular Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2023 | Cepheid Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, Open, Classified |
PGX | K172126 |
| Nov 2, 2023 | Cepheid Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only Open, Classified |
PGX | K172126 |
| Aug 15, 2019 | Luminex Corporation ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469 Open, Classified |
PGX | K172402 |
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2850, MOL1451, MOL1452, MOL1455 Terminated |
PGX | K143651 |
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