BEUDAMED
    Product Code: DCN FDA class 2 21 CFR 866.5270

    System, Test, C-Reactive Protein

    Immunology

    This is a test system for detecting and quantifying C-reactive protein (CRP) in clinical specimens, providing an immunoassay platform for measuring this widely used inflammatory marker in the evaluation of infection, autoimmune disease, and cardiovascular risk. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DCN, regulated under 21 CFR 866.5270, within the Immunology specialty.

    View on FDA
    510(k)s
    70
    FEI Numbers
    33
    Registration Numbers
    33
    Unique Applicants
    53
    Years Active
    46

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    Basic Information

    Product Code
    DCN
    Device Class
    FDA class 2
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 70 510(k) clearances via K numbers.

    K Number Device Name
    K232624 CardioPhase® hsCRP
    K221119 RCRP Flex reagent cartridge
    K192072 Tina-quant C-Reactive Protein IV
    K180099 Optilite High Sensitivity C-Reactive Protein Kit
    K172868 Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
    K171498 MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
    K161982 C-Reactive Protein Kit for use on SPAPLUS
    K113809 HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
    K091052 PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
    K083444 C-REACTIVE PROTEIN (LATEX)
    K083412 PATHFAST HSCRP
    K083040 S-TEST C-REACTIVE PROTEIN (CRP)
    K072658 ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
    K073277 ROCHE-CREACTIVE PROTEIN (LATEX)
    K062981 I-CHROMA CRP TEST
    K061825 DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
    K050713 DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
    K040030 BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
    K032336 TINA-QUANT CRP (LATEX)
    K030899 C-REACTIVE PROTEIN (CRP)
    K022690 PAROS CRP
    K021757 CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
    K021572 SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR
    K021882 CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
    K020603 CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
    K011855 WAMPOLE HS-CRP ELISA
    K012337 BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
    K011958 CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
    K003400 CRP HS TEST SYSTEM
    K003419 RCRP FLEX REAGENT CARTRIDGE
    K003342 WAKO CRP-UL, CRP-UL CALIBRATOR SET
    K003372 IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
    K002918 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
    K991372 CRP
    K990825 REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
    K974429 RAPET CRP
    K954537 OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
    K955042 CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
    K935075 SPQ CRP CONTROL LEVEL II
    K932180 EYE SPOT CRP TEST
    K910535 SYNCHRON C-REACTIVE PROTEIN REAGENT
    K910686 RHEUMAJET CRP
    K904497 CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
    K903853 RAPITEX (R) CRP NEW
    K902593 RAICHEM(TM) SPIA(TM) CRP REAGENT
    K896272 QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
    K892231 V-TREND TARGET CRP TEST
    K885001 QM300 PCR ANTIBODY PACK
    K883515 DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
    K882374 WAKO(TM) CRP
    K880728 KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
    K872539 EUROGENETICS CRP ELISA
    K860679 IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
    K855057 LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
    K854819 CPR SLIDE EIKEN
    K841265 TAGO DIFFU-GEN C-REACTIVE PROTEIN
    K840699 CRP SLIDE TEST KIT
    K834584 NABI CRP-Q.S. TEST
    K834390 IMMUNO-CRP
    K831465 CRP-CHECK
    K831364 TESTCORP RA
    K831362 TESTCORP CRP
    K821388 SERO/TEX CRP TEST
    K821413 EMIT C-REACTIVE PROTEIN ASSAY
    K812881 IMMUNEX CRP
    K811374 BI-CRP LATEX TEST
    K810862 CRP SLIDE
    K790716 ANTISERUM TO HUMAN C-REACTIVE PROTEINS
    K771535 LAS-R HUMAN CRP TEST
    K771139 CRP-WELLCOTEST

    FEI Numbers

    This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.