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FDA product code QPS

Immunoassay For Host Biomarkers Of Infection

MicrobiologyClass 221 CFR 866.3215
Verified
US regulatory classifications
US Product Code (FDA)
QPS
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3215
View CFR Regulation
Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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

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01Immunoassay02Infection test03Biomarker test04Host biomarker05Infection assay06Diagnostic test07Sepsis test08Immune test09Lab test10Infection screen
About this record

Immunoassay For Host Biomarkers Of Infection is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.