The following data is part of a premarket notification filed by Quest International, Inc. with the FDA for Seraquest Hsv Type 2 Specific Igg.
| Device ID | K181514 |
| 510k Number | K181514 |
| Device Name: | SeraQuest HSV Type 2 Specific IgG |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Applicant | Quest International, Inc. 1935 SW Martin Highway Palm City, FL 34990 |
| Contact | Steve Andrus |
| Correspondent | Steve Andrus Quest International, Inc. 1935 SW Martin Highway Palm City, FL 34990 |
| Product Code | MYF |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-08 |
| Decision Date | 2019-06-13 |