inforMED
PMTClass II

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

Microbiology · 21 CFR 866.3215

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.

MDR events13All time
Recalls1All time
Registered firms23Currently listed
510(k) clearances5All time

Recent MDR events

13 adverse event reports on file

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Event type breakdown

Malfunction13

Most-reported manufacturers

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Roche Diagnostics8Ortho-clinical Diagnostics, Inc.4Roche Diagnostics Corp.1

Recalls

1 recall events for this product code

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Registered firms

23 firms currently registered for this product code

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510(k) clearances

5 clearances for this product code

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