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Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
FDA product code NQD · Class 2 · Immunology
23
Registered devices
19
Adverse events
3
Recalls
19
510(k) clearances
Devices with this code
Dimension CardioPhase high sensitivity CRP Flex reagent cartridge — Siemens Healthcare Diagnostics Inc.Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems hsC High Sensitivity CRP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCardiac C-Reactive Protein (Latex) High Sensitive — Roche Diagnostics GmbHIMMULITE® 2000 Systems CRP CRP Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSynchron — Beckman Coulter, Inc.IMMULITE®/IMMULITE® 1000 Systems CRP Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCardioPhase® hsCRP — Siemens Healthcare Diagnostics Products GmbHARCHITECT — ABBOTT LABORATORIESIMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDARCHITECT — ABBOTT LABORATORIESAtellica CH hsCRP — Siemens Healthcare Diagnostics Inc.Dimension Vista hsCRP Flex reagent cartridge — Siemens Healthcare Diagnostics Products GmbHCardioPhase® hsCRP — Siemens Healthcare Diagnostics Products GmbHAU — Beckman Coulter, Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein — Siemens Healthcare Diagnostics Inc.IMMULITE® Systems CRP CONTROL C-Reactive Protein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMAGE — Beckman Coulter, Inc.Tinaquant Cardiac Creactive Protein Latex High Sensitive — Roche Diagnostics GmbHCardiac CReactive Protein Latex High Sensitive — Roche Diagnostics GmbHAlinity — ABBOTT LABORATORIESCardiac CReactive Protein Latex High Sensitive — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-02-26 | Roche Diagnostics Operations, Inc. | Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at con |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
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