ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls— 510(k) K213987

Name: FDA 510(k) clearance K213987
Creator: U.S. Food and Drug Administration
Published: 2023-09-20

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K213987 for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls, Substantially Equivalent on 2023-09-20. Applicant: Biokit, S.A.. Device class: 2.

Clearance details

Applicant: Biokit, S.A.
Product code: Code MXJ
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2021-12-20
Decision date: 2023-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lliçà D´Amunt, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code MXJ

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K220923 — Elecsys HSV-1 IgG (08948844160)2022-10-12
K181333 — ADVIA Centaur Herpes-1 IgG2018-08-23
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

More clearances from Biokit, S.A.

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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

Adverse events under product code MXJ

product code MXJ

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.