PMT · Class II · 21 CFR 866.3215

FDA Product Code PMT: Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens

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.

Leading manufacturers include bioMerieux, Inc., Siemens Healthcare Diagnostics, Inc. and Ortho-Clinical Diagnostics.

5
Total
4
Cleared
129d
Avg days
2016
Since

FDA 510(k) Cleared Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens Devices (Product Code PMT)

5 devices
1–5 of 5
Cleared Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
K200236
Ortho-Clinical Diagnostics
Microbiology · 26d
Cleared Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
K181002
Siemens Healthcare Diagnostics, Inc.
Microbiology · 91d
Cleared Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
K160911
bioMerieux, Inc.
Microbiology · 88d

About Product Code PMT - Regulatory Context