FDA 510(k) Applications for Medical Device Product Code "PGI"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K233349 | Abbott Molecular Inc | Alinity m HSV 1 & 2 / VZV | 05/03/2024 |
| DEN140004 | DIAGNOSTIC HYBRIDS, INC. | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | 05/13/2014 |
| K173798 | DiaSorin Molecular LLC | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | 03/14/2018 |
| K192376 | DiaSorin Molecular LLC | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | 11/26/2019 |
| K180559 | ELITechGroup | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | 10/29/2018 |
| K151906 | LUMINEX CORPORATION | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) | 10/06/2015 |
| K151046 | MERIDIAN BIOSCIENCE, INC. | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 | 07/17/2015 |
| K232286 | Quidel Corporation | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | 12/20/2023 |
| K162451 | QUIDEL CORPORATION | Solana HSV 1+2/VZV Assay | 11/28/2016 |
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