DCN · System, Test, C-Reactive Protein
Immunology · 21 CFR 866.5270 · Class 2
Overview
| Product Code | DCN |
|---|---|
| Device Name | System, Test, C-Reactive Protein |
| Regulation | 21 CFR 866.5270 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 70)
Showing 20 most recent of 70 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | Nov 27, 2023 | SESE |
| K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | Mar 17, 2023 | SESE |
| K192072 | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | Feb 21, 2020 | SESE |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. | Oct 12, 2018 | SESE |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | The Binding Site Group , Ltd. | Feb 28, 2018 | SESE |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC | Jan 12, 2018 | SESE |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | Apr 5, 2017 | SESE |
| K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) | Hitachi Chemical Diagnostics, Inc. | Aug 17, 2012 | SESE |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | Abaxis, Inc. | Jan 15, 2010 | SESE |
| K083444 | C-REACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | Mar 18, 2009 | SESE |
| K083412 | PATHFAST HSCRP | Mitsubishi Kagaku Iatron | Mar 9, 2009 | SESE |
| K083040 | S-TEST C-REACTIVE PROTEIN (CRP) | Alfa Wassermann Diagnostic Technologies, Inc. | Jan 30, 2009 | SESE |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | Siemens Medical Solutions Diagnostics | Apr 1, 2008 | SESE |
| K073277 | ROCHE-CREACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | Mar 6, 2008 | SESE |
| K062981 | I-CHROMA CRP TEST | Boditech Diagnostics, Inc. | Jul 13, 2007 | SESE |
| K061825 | DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH | Dade Behring, Inc. | Sep 6, 2006 | SESE |
| K050713 | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 | Good Biotech Corp. | Jun 6, 2005 | SESE |
| K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | Biocheck, Inc. | Jun 16, 2004 | SESE |
| K032336 | TINA-QUANT CRP (LATEX) | Roche Diagnostics Corp. | Aug 5, 2003 | SESE |
| K030899 | C-REACTIVE PROTEIN (CRP) | Abbott Laboratories | Jul 2, 2003 | SESE |
Top Applicants
- Roche Diagnostics Corp. — 4 clearances
- Good Biotech Corp. — 4 clearances
- Dade Behring, Inc. — 3 clearances
- Wako Chemicals USA, Inc. — 2 clearances
- The Binding Site Group , Ltd. — 2 clearances
