Panels › Immunology › Product code NQD · Class 2
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Regulation 866.5270
1510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NQD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2026 | K260026 | Tina-quant Cardiac high sensitivity CRP III Roche Diagnostics | NQD |
| Jan 18, 2024 | K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) Siemens Healthcare Diagnostics, Inc. | NQD |
| Dec 16, 2022 | K212559 | CardioPhase® hsCRP Siemens Healthcare Diagnostics Products GmbH, DE | NQD |
| Sep 27, 2018 | K173833 | CRP Vario SENTINEL CH. SpA, IT | NQD |
| Jul 29, 2008 | K081294 | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS Siemens Healthcare Diagnostics, Inc. | NQD |
| Jun 21, 2007 | K071002 | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT Beckman Coulter, Inc. | NQD |
| May 4, 2007 | K070626 | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT Beckman Coulter, Inc. | NQD |
| May 2, 2007 | K071017 | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) Siemens Medical Solutions Diagnostics | NQD |
| Dec 26, 2006 | K062924 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK Dade Behring, Inc. | NQD |
| Dec 22, 2006 | K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP Diagnostic Products Corporation | NQD |
| Sep 11, 2006 | K061802 | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH Dade Behring, Inc. | NQD |
| May 4, 2006 | K060369 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK Dade Behring, Inc. | NQD |
| Feb 9, 2006 | K053603 | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS Roche Diagnostics Corp. | NQD |
| Dec 23, 2005 | K053109 | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE Dade Behring, Inc. | NQD |
| Aug 22, 2005 | K051564 | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH Olympus America, Inc. | NQD |
| Oct 29, 2004 | K042485 | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) Roche Diagnostics Corp. | NQD |
| Aug 25, 2004 | K041799 | VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS Ortho-Clinical Diagnostics, Inc. | NQD |
| Aug 19, 2004 | K041668 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | NQD |
| Jan 22, 2004 | K033908 | N HIGH SENSITIVITY CRP Dade Behring, Inc. | NQD |
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