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Antigen, Inflammatory Response Marker, Sepsis

FDA product code NTM · 3 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3210
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-01-07 – 2008-03-31

An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.

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