The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Solana Hsv 1+2/vzv Assay.
| Device ID | K162451 |
| 510k Number | K162451 |
| Device Name: | Solana HSV 1+2/VZV Assay |
| Classification | Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Applicant | QUIDEL CORPORATION 2005 EAST STATE STREET, SUITE 100 Athens, OH 45701 |
| Contact | Ronald H. Lollar |
| Correspondent | Ronald H. Lollar QUIDEL CORPORATION 2005 EAST STATE STREET, SUITE 100 Athens, OH 45701 |
| Product Code | PGI |
| CFR Regulation Number | 866.3309 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-01 |
| Decision Date | 2016-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613336105 | K162451 | 000 |