Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Immunoassay For Host Biomarkers Of Infection

FDA product code QPS · 4 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3215
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-09-01 – 2023-06-30

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

↑