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Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
FDA product code PMT · Class 2 · Microbiology
17
Registered devices
13
Adverse events
1
Recalls
5
510(k) clearances
Devices with this code
Atellica IM BRAHMS PCT — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHB.R.A.H.M.S PCT sensitive KRYPTOR — B.R.A.H.M.S GmbHVITROS — ORTHO CLINICAL DIAGNOSTICSElecsys BRAHMS PCT — Roche Diagnostics GmbHARCHITECT — Abbott GmbHARCHITECT — Abbott GmbHLumipulse BRAHMS PCT Controls — FUJIREBIO INC.VITROS — ORTHO CLINICAL DIAGNOSTICSVITROS — ORTHO CLINICAL DIAGNOSTICSDM EXL LOCI BRAHMS PCT — Siemens Healthcare Diagnostics Inc.Lumipulse G BRAHMS PCT Immunoreaction Cartridges — FUJIREBIO INC.Elecsys BRAHMS PCT — Roche Diagnostics GmbHVITROS — ORTHO CLINICAL DIAGNOSTICSAlinity — Abbott Ireland DiagnosticsARCHITECT — Abbott GmbHVIDAS® B·R·A·H·M·S PCT ™ — BIOMERIEUX SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-22 | Roche Diagnostics Corporation | Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers. |
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