The following data is part of a premarket notification filed by Biokit, S.a. with the FDA for Advia Centaur Herpes-1 Igg.
| Device ID | K181333 |
| 510k Number | K181333 |
| Device Name: | ADVIA Centaur Herpes-1 IgG |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | Biokit, S.A. Can Male S/N Llica D’amunt, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer Biokit, S.A. Can Male S/N Llica D’amunt, ES 08186 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-21 |
| Decision Date | 2018-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414016740 | K181333 | 000 |
| 00842768022784 | K181333 | 000 |