The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Vzv Swab Direct, Simplexa Vzv Positive Control Pack.
| Device ID | K192376 |
| 510k Number | K192376 |
| Device Name: | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack |
| Classification | Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Applicant | DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Contact | Sharon Young |
| Correspondent | Sharon Young DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Product Code | PGI |
| CFR Regulation Number | 866.3309 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2019-11-26 |
| Summary: | summary |