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QPS — Immunoassay For Host Biomarkers Of Infection Class II

FDA Device Classification

Classification Details

Product Code
QPS
Device Class
Class II
Regulation Number
866.3215
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230944memed diagnosticsMeMed BVJune 30, 2023
K222332memed diagnosticsMeMed BVMarch 23, 2023
K213936diasorinLIAISON MeMed BV, LIAISON MeMed BV Control SetJuly 14, 2022
K210254memed diagnosticsMeMed BVSeptember 1, 2021