MSV

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Product code
MSV
Device name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device class
Class 2
21 CFR
21 CFR 866.5660
Medical specialty
Immunology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
46 (all years; only the last 3 years are listed here)

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

Last three years. Most recent: 2026-02-06.

NumberDecision dateApplicantDevice nameSummary
K2439792026-02-06Inova Diagnostics, Inc.Aptiva APS IgA ReagentPDF

1 summaries are archived here for direct download.

Official FDA classification page: MSV
Classification and pathway per current FDA publications. Data from openFDA (CC0).