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

FDA product code PMT · 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
2016-06-13 – 2020-02-25

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.

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