FDA Device Intelligence
Home › Device types › PRI

Procalcitonin Assay

FDA product code PRI · Class 2 · Microbiology

14
Registered devices
213
Adverse events
1
Recalls
8
510(k) clearances

Devices with this code

Atellica IM BRAHMS PCT — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHElecsys BRAHMS PCT — Roche Diagnostics GmbHB.R.A.H.M.S PCT sensitive KRYPTOR — B.R.A.H.M.S GmbHARCHITECT — Abbott GmbHARCHITECT — Abbott GmbHLumipulse BRAHMS PCT Controls — FUJIREBIO INC.DM EXL LOCI BRAHMS PCT — Siemens Healthcare Diagnostics Inc.Lumipulse G BRAHMS PCT Immunoreaction Cartridges — FUJIREBIO INC.Elecsys BRAHMS PCT — Roche Diagnostics GmbHElecsys BRAHMS PCT — Roche Diagnostics GmbHAlinity — Abbott Ireland DiagnosticsARCHITECT — Abbott GmbHVIDAS® B·R·A·H·M·S PCT ™ — BIOMERIEUX SA

Recent recalls

DateFirmReason
2021-09-22bioMerieux, Inc.bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.