FDA Product Code PRI: Procalcitonin Assay
To Aid In Decision Making On Antibiotic Therapy, Including Antibiotic Initiation And Discontinuation, For Inpatients Or Patients In The Emergency Department, With Suspected Or Confirmed Lower Respiratory Tract Infections (lrti) Defined As Community-acquired Pneumonia (cap), Acute Bronchitis, And Acute Exacerbation Of Chronic Obstructive Pulmonary Disease (aecopd).
Leading manufacturers include Siemens Healthcare Diagnostics, Inc..
List of Procalcitonin Assay devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Procalcitonin Assay devices (product code PRI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →