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QPSClass II

Immunoassay For Host Biomarkers Of Infection

21 CFR 866.3215 / Microbiology
FDA source (opens on fda.gov)

QPS is the FDA product code for Immunoassay For Host Biomarkers Of Infection, a class II device type, regulated under 21 CFR 866.3215. FDA's definition for this code reads: "A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QPS
Device name
Immunoassay For Host Biomarkers Of Infection
FDA definition
A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code QPS

By decision year
4 clearances under product code QPS with a decision year between 2021 and 2023, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QPS by decision year
YearClearances
20211
20221
20232

Applicants with the most clearances

Product code QPS
Applicants holding the most 510(k) clearances under product code QPS
ApplicantClearances
MeMed Diagnostics Ltd3
Diasorin Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code