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 Roche Diagnostics, bioMerieux, Inc. and Siemens Healthcare Diagnostics, Inc..
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
Cleared
Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
Ortho-Clinical Diagnostics
Microbiology
26d
Cleared
Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
Siemens Healthcare Diagnostics, Inc.
Microbiology
91d
Cleared
Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
bioMerieux, Inc.
Microbiology
88d
Cleared
Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
Roche Diagnostics
Microbiology
89d