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HepQuant SHUNT® Liver Diagnostic Test

by Hepquant, LLC United States PMA

PMA P220016 Product code SIO

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP220016 Date18 Jun 2026ApprovedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

PMA · synced 22 Oct 2026

Generic Name
Test for Esophageal Varices
PMA Number
FDA Product Code
SIO
Device Class
Class III
Advisory Committee
Clinical Chemistry
FDA Decision
APPR Approved

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P220016 24 fields · synced 22 Oct 2026