Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Medical specialty
Microbiology
Device class
2
Regulation number
866.3215
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.