ADVIA Centaur Herpes-1 IgG— 510(k) K181333

Clearance details

Applicant

Biokit, S.A.

Product code

Code MXJ

Device class

Class 2

Regulation

21 CFR 866.3305

Advisory panel

Microbiology

Date received

2018-05-21

Decision date

2018-08-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lliça D'Amunt, ES

• K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls2023-09-20
• K220923 — Elecsys HSV-1 IgG (08948844160)2022-10-12
• K162276 — SeraQuest Herpes Type 1 Specific IgG2016-10-01
• K143236 — Theranos Herpes Simplex Virus-1 IgG Assay2015-07-02
• K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST2014-02-28

• K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls2025-02-12
• K233605 — ADVIA Centaur EBV-EBNA IgG2024-08-07
• K233606 — ADVIA Centaur EBV-VCA IgM2024-08-07
• K214068 — Quantia IgE2023-02-21
• K181334 — ADVIA Centaur Herpes-2 IgG2018-08-23

Injury

139

Total

139

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →