Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
FDA product code NQD · 19 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.5270
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 2004-01-22 – 2026-04-02
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
NQD
2026-04-02
NQD
2024-01-18
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
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NQD
2022-12-16
CardioPhase® hsCRP
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NQD
2018-09-27
CRP Vario
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NQD
2008-07-29
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
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NQD
2007-06-21
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
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NQD
2007-05-04
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
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NQD
2007-05-02
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
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NQD
2006-12-26
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
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NQD
2006-12-22
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
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NQD
2006-09-11
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
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NQD
2006-05-04
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
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NQD
2006-02-09
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
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NQD
2005-12-23
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
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NQD
2005-08-22
OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
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NQD
2004-10-29
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
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NQD
2004-08-25
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
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NQD
2004-08-19
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
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NQD
2004-01-22
N HIGH SENSITIVITY CRP
View details →No matching devices.
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