FDA Product Code QPS: Immunoassay For Host Biomarkers Of Infection
A Semi-quantitative Immunoassay That Quantifies The Relative Levels Of Host Response Proteins Isolated From Serum Or Similar Specimens.
Leading manufacturers include DiaSorin, Inc..
4
Total
4
Cleared
186d
Avg days
2021
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Immunoassay For Host Biomarkers Of Infection Devices (Product Code QPS)
4 devices
Cleared
Jul 14, 2022
LIAISON MeMed BV, LIAISON MeMed BV Control Set
DiaSorin, Inc.
Microbiology
210d
About Product Code QPS - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QPS since 2021, with 4 receiving FDA clearance (average review time: 186 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
QPS devices are reviewed by the Microbiology panel. Browse all Microbiology devices →