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Antigen, Inflammatory Response Marker, Sepsis
FDA product code NTM · Class 2 · Microbiology
16
Registered devices
8
Adverse events
2
Recalls
3
510(k) clearances
Devices with this code
Atellica IM PCT — Siemens Healthcare Diagnostics Inc.PCT AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.B.R.A.H.M.S PCT sensitive KRYPTOR — B.R.A.H.M.S GmbHLumipulse G BRAHMS PCT Calibrator Set — FUJIREBIO INC.Nano-CheckTM PCT — NANO-DITECH CORPORATIONAtellica IM PCT QC — Siemens Healthcare Diagnostics Inc.PCT AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.Lumipulse BRAHMS PCT Controls — FUJIREBIO INC.Fluoro-CheckTM PCT — NANO-DITECH CORPORATIONB.R.A.H.M.S PCT LIA — B.R.A.H.M.S GmbHLumipulse G BRAHMS PCT Immunoreaction Cartridges — FUJIREBIO INC.Nano-CheckTM PCT plus — NANO-DITECH CORPORATIONPCT AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.B.R.A.H.M.S Basiskit LIA — B.R.A.H.M.S GmbHPCT AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.VIDAS® B·R·A·H·M·S PCT ™ — BIOMERIEUX SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2014-04-10 | Siemens Healthcare Diagnostics, Inc | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. |
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