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System, Test, C-Reactive Protein
FDA product code DCN · Class 2 · Immunology
61
Registered devices
49
Adverse events
6
Recalls
70
510(k) clearances
Devices with this code
C-Reactive Protein Kit for SPAPLUS — THE BINDING SITE GROUP LIMITEDAIM CRP TEST — GERMAINE LABORATORIES, INCTina-quant CReactive Protein IV — Roche Diagnostics GmbHASI Disposable Test Card — ARLINGTON SCIENTIFIC, INC.ASI CRP Slide Test — ARLINGTON SCIENTIFIC, INC.RaPET® CRP — STANBIO LABORATORY, L.P.Tina-quant CReactive Protein IV — Roche Diagnostics GmbHRapiTex® CRP — Siemens Healthcare Diagnostics Products GmbHASI CRP Slide Test — ARLINGTON SCIENTIFIC, INC.Detector Lex-CRP — Immunostics Company, IncOptilite C-Reactive Protein Reagent — THE BINDING SITE GROUP LIMITEDAtellica CH CRP_2 — Siemens Healthcare Diagnostics Inc.Optilite High Sensitivity C-Reactive Protein Kit — THE BINDING SITE GROUP LIMITEDTinaquant CReactive Protein Gen3 — Roche Diagnostics GmbHTina-quant C-Reactive Protein IV — Roche Diagnostics GmbHPiccolo AmLyte 13 — ABAXIS, INC.Nano-Check TM CRP plus Test — NANO-DITECH CORPORATIONASI CRP Slide Test — ARLINGTON SCIENTIFIC, INC.IMMUNEX CRP® — ALERE NORTH AMERICA, LLCNano-CheckTM hs-CRP — NANO-DITECH CORPORATIONSure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Tinaquant CReactive Protein Gen3 — Roche Diagnostics GmbHRheumajet CRP 100 TESTS — BIOKIT, S.A.Piccolo MetLyte Plus CRP — ABAXIS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-17 | Siemens Healthcare Diagnostics, Inc. | The potential for falsely elevated results. |
| 2025-03-11 | Siemens Healthcare Diagnostics, Inc. | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. |
| 2020-11-06 | Roche Diagnostics Operations, Inc. | Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 |
| 2019-04-25 | The Binding Site Group, Ltd. | A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected |
| 2019-02-19 | The Binding Site Group, Ltd. | Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits |
| 2008-04-15 | Siemens Healthcare Diagnostics, Inc. | falsely elevated results in EDTA plasma samples |
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