Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

PMT · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215

Classification

FDA Product Code: PMT
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

An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 21

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown