Product code NQD
- Device name
- Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5270
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026-04-02 |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | 2024-01-18 |
| K212559 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | 2022-12-16 |
| K173833 | CRP Vario | SENTINEL CH. SpA | 2018-09-27 |
| K081294 | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2008-07-29 |
| K071002 | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | Beckman Coulter, Inc. | 2007-06-21 |
| K070626 | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | Beckman Coulter, Inc. | 2007-05-04 |
| K071017 | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) | Siemens Medical Solutions Diagnostics | 2007-05-02 |
| K062924 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | Dade Behring, Inc. | 2006-12-26 |
| K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | Diagnostic Products Corporation | 2006-12-22 |
| K061802 | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH | Dade Behring, Inc. | 2006-09-11 |
| K060369 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | Dade Behring, Inc. | 2006-05-04 |
| K053603 | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS | Roche Diagnostics Corp. | 2006-02-09 |
| K053109 | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2005-12-23 |
| K051564 | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH | Olympus America, Inc. | 2005-08-22 |
| K042485 | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) | Roche Diagnostics Corp. | 2004-10-29 |
| K041799 | VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 |
| K041668 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 2004-08-19 |
| K033908 | N HIGH SENSITIVITY CRP | Dade Behring, Inc. | 2004-01-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414305028 | Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics Inc. | 2024-06-11 |
| 00630414611112 | Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics Inc. | 2024-06-11 |
| 07613336121207 | Cardiac C-Reactive Protein (Latex) High Sensitive | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740181024 | Alinity | ABBOTT LABORATORIES | 2020-01-13 |
| 00380740180331 | Alinity | ABBOTT LABORATORIES | 2020-01-13 |
| 00380740158507 | ARCHITECT | ABBOTT LABORATORIES | 2018-12-28 |
| 00380740158491 | ARCHITECT | ABBOTT LABORATORIES | 2018-12-28 |
| 00630414596174 | Atellica CH hsCRP | Siemens Healthcare Diagnostics Inc. | 2017-12-21 |
| 15099590010959 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 00630414963792 | IMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414961200 | IMMULITE® 2000 Systems hsC High Sensitivity CRP | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00842768006135 | Dimension Vista hsCRP Flex reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768007729 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768007736 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768016028 | Dimension CardioPhase high sensitivity CRP Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414552699 | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414953144 | IMMULITE® Systems CRP CONTROL C-Reactive Protein | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414953670 | IMMULITE®/IMMULITE® 1000 Systems CRP Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414953687 | IMMULITE® 2000 Systems CRP CRP Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 04015630912209 | Tinaquant Cardiac Creactive Protein Latex High Sensitive | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921508 | Cardiac CReactive Protein Latex High Sensitive | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630928774 | Cardiac CReactive Protein Latex High Sensitive | Roche Diagnostics GmbH | 2016-09-20 |
| 10758750006885 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 15099590228682 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590203160 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |