Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
PTF · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215
Classification
FDA Product Code
PTF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3215
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock