MXJ

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Product code: MXJ
Device name: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device class: Class 2
21 CFR: 21 CFR 866.3305
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1
Summaries archived here: 0 (direct download)
510(k) clearances (all years, FDA): 20 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-20.

Number	Decision date	Applicant	Device name	Summary
K213987	2023-09-20	Biokit, S.A.	ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator,…	FDA

Official FDA classification page: MXJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).