BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    SENTINEL CH. SPA

    Reg #: 9681753 · FEI: 3000303338 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    68
    Establishment Types
    3
    Classifications
    27

    Registration Details

    Registration Name
    SENTINEL CH. SPA
    Registration Number
    9681753
    FEI Number
    3000303338
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA ROBERT KOCH, 2
    City
    MILANO
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K051111

    Owner / Operator

    Firm Name
    SENTINEL CH. SpA
    Operator Number
    9025279
    Address
    Via Robert Koch, 2
    City
    Milan
    State
    Milano
    Postal Code
    20152
    Country
    IT

    US Agent

    Business Name
    Diagnostic Oncology CRO, LLC
    Contact Name
    Robert McNamee
    Address
    1 Jacks Hill Rd Ste 1ab
    City
    Oxford
    State
    CT
    ZIP
    06478
    Country
    US
    Email
    [email protected]
    Phone
    203 5989105

    Products

    Device Name Product Code
    Bathophenanthroline, Iron Binding Capacity JQF
    Calibrator, Multi-Analyte Mixture JIX
    Lambda, Antigen, Antiserum, Control DEH
    Indirect Copper Assay, Ceruloplasmin JFR
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Catalytic Methods, Amylase JFJ
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection PHP
    Test, Cystatin C NDY
    Calibrator, Secondary JIT
    Enzymatic Method, Ammonia JIF
    Radioassay, Angiotensin Converting Enzyme KQN
    Calibrator, Primary JIS
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Assay, Porphyrin, Spectrophotometry, Lithium NDW
    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD
    Enzymatic Method, Creatinine JFY
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Differential Rate Kinetic Method, Cpk Or Isoenzymes JHS
    Kappa, Antigen, Antiserum, Control DFH
    Bromcresol Purple Dye-Binding, Albumin CJW
    Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase DLI
    Hysteroscope (And Accessories) HIH
    Photometric Method, Iron (Non-Heme) JIY
    Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control LKL

    Proprietary Names

    UIBC UIBC LIQUID PLASMAPROTEINS CAL 3X Alinity c UIBC Reagent Kit Lambda Light Chains Alinity c Ceruloplasmin Reagent Kit Ceruloplasmin Sentinel Lipase Liquid Lipase NG Lipase NG OC Reagent Kit PANCREATIC AMYLASE Plasmaproteins Cal 3x ACE Control Set Lp(a) Ultra ColoHealth Cystatin C CERULOPLASMIN Alinity c UIBC Calibrator Kit Lipase NG OC Cal Lp(a) Cal Set ACE Calibrator Cystatin C Calibrators Lipase NG Cal AMMONIA CONTROLS Alinity c Ammonia Ultra Reagent Kit AMMONIA ULTRA ACE Liquid ACE Reagent CRP VARIO CRP CALIBRATOR SET CRP CALIBRATOR HS Alinity c CRP Vario HS Control Kit CRP CONTROL HS CRP CALIBRATOR WR Multigent Lithium Assay Alinity c Lithium Reagent Kit Alinity c Ammonia Controls Lipase NG OC CTRL 2 Lipase NG OC CTRL 1 Lp(a) Control Set ACE Control Cystatin C Controls CRP Vario Alinity c CRP Vario Reagent Kit Creatinine (Enzymatic) Alinity c Creatinine (Enzymatic) Reagent Kit ARCHITECT c ACE Assay File Alinity c ACE Assay File CKMB UDR Alinity c Plasmaproteins Cal 3x Kit Alinity c Clinical Chemistry Calibrator Kit Clin Chem Cal Alinity c CRP Vario Wide Range Calibrator Kit Alinity c CRP Vario High Sensitivity Calibrator Kit Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit Kappa Light Chains Albumin BCP (6x20 mL) Albumin BCP (6x50 mL) Cholinesterase Sentinel Iron Liquid IRON LIQUID Iron Immuno Control Set Clin Chem Control 2 Clin Chem Control 1 Alinity c Iron Reagent Kit Alpha 1-Acid Glycoprotein Alinity c Reagent Cartridge Black

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)