DeviceClearance

Product code QPS— Microbiology

MeMed BV

Classification name
Immunoassay For Host Biomarkers Of Infection
Device class
Class 2
Regulation
21 CFR 866.3215
Advisory panel
Microbiology
Total cleared
4
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QPS under 21 CFR 866.3215, via openFDA

Market context for product code QPS

FDA has cleared 4 devices under product code QPS between 2021 and 2023, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QPS

Recent clearances under product code QPS

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