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System, Test, C-Reactive Protein
FDA product code DCN · Class 2 · Immunology
61
Registered devices
50
Adverse events
5
Recalls
70
510(k) clearances
Devices with this code
Detector Lex-CRP — Immunostics Company, IncASI CRP Control Set — ARLINGTON SCIENTIFIC, INC.Optilite C-Reactive Protein Controls — THE BINDING SITE GROUP LIMITEDAtellica CH CRP_2 — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.Dimension® Flex® reagent cartridge RCRP — Siemens Healthcare Diagnostics Inc.CReactive Protein Gen3 — Roche Diagnostics GmbHRapiTex® CRP — Siemens Healthcare Diagnostics Products GmbHTina-quant C-Reactive Protein IV — Roche Diagnostics GmbHCardiac CReactive Protein Latex High Sensitive — Roche Diagnostics GmbHASI CRP Slide Test — ARLINGTON SCIENTIFIC, INC.ASI CRP Slide Test — ARLINGTON SCIENTIFIC, INC.ichroma Reader — Boditech Med Inc.ASI CRP Slide Test — ARLINGTON SCIENTIFIC, INC.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.ASI CRP Slide Test — ARLINGTON SCIENTIFIC, INC.ichroma™ CRP — Boditech Med Inc.RaPET® CRP — STANBIO LABORATORY, L.P.Detector Lex-CRP — Immunostics Company, IncRapiTex® CRP — Siemens Healthcare Diagnostics Products GmbHTina-quant CReactive Protein IV — Roche Diagnostics GmbHAtellica CH Revised C-Reactive Protein (RCRP) — Siemens Healthcare Diagnostics Inc.ASI Disposable Test Card — ARLINGTON SCIENTIFIC, INC.CReactive Protein Gen3 — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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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