BEUDAMED
    FDA Registration Active 🇫🇷 France

    VitalScientific

    Reg #: 3007662974 · FEI: 3007662974 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    115
    Establishment Types
    2
    Classifications
    37

    Registration Details

    Registration Name
    VitalScientific
    Registration Number
    3007662974
    FEI Number
    3007662974
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zone Industrielle, 13 rue Auguste Mottin
    City
    SEES Normandie
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K113269

    Owner / Operator

    Firm Name
    VitalScientific
    Operator Number
    10090892
    Address
    13 Rue Auguste Mottin - Zone Industrielle
    City
    SEES
    State
    Orne
    Postal Code
    61500
    Country
    FR
    Correspondent
    Valerie LAMBERT

    US Agent

    Business Name
    Clinical Diagnostic Solutions, Inc
    Contact Name
    Junelle Goldson
    Address
    1800 Nw 65th Ave
    City
    Plantation
    State
    FL
    ZIP
    33313
    Country
    US
    Email
    [email protected]
    Phone
    954 7911773

    Products

    Device Name Product Code
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Enzymatic Method, Creatinine JFY
    Calibrator, Multi-Analyte Mixture JIX
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    System, Test, Low Density, Lipoprotein MRR
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Acid, Uric, Uricase (Colorimetric) KNK
    Electrode, Ion Selective (Non-Specified) JJP
    General Purpose Reagent PPM
    Hexokinase, Glucose CFR
    U.V. Method, Cpk Isoenzymes JHW
    Catalytic Methods, Amylase JFJ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Diazo Colorimetry, Bilirubin CIG
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Enzymatic, Carbon-Dioxide KHS
    Biuret (Colorimetric), Total Protein CEK
    Azo Dye, Calcium CJY
    Assay, Glycosylated Hemoglobin LCP
    Photometric Method, Iron (Non-Heme) JIY
    Bromcresol Green Dye-Binding, Albumin CIX
    Photometric Method, Magnesium JGJ
    Glucose Oxidase, Glucose CGA
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion-Specific, Chloride CGZ
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL

    Proprietary Names

    ALP IFCC SL, 8 x 12.5 mL, REF PISL-0210-NA ELICAL 2, 4 x 3 mL, REF CALI-0580 ELITROL I, 10 x 5 mL, REF CONT-0080 ELITROL II, 10 x 5 mL, REF CONT-0180 Creatinine PAP SL, 8 x 28 mL, REF CRSL-0250-NA URINE CONTROL BI-LEVEL, Ref. CTUR-0610 URINE TOTAL PROTEIN PLUS STANDARD 100 mg/dL; Ref. PRTU-0025 LIPASE ENVOY, REF LPSL-0850-NA Lipase SL, 4 x 9.2 mL, REF LPSL-0230-NA Cholesterol HDL 2G Calibrator, 4 x 1 mL, Ref. HDLL-0041-NA Cholesterol LDL 2G Calibrator, 4 x 1 mL, Ref. LDLL-0041-NA Cholesterol HDL SL 2G, 4 x 28 mL, REF HDLL-0230-NA Cholesterol LDL SL 2G, 4 x 28 mL, REF LDLL-0230-NA ELITROL II, Ref. CONT-0180 ELITROL I, Ref. CONT-0080 ENVOY® 500 Triglycerides Reagent Kit, REF 55435 Triglycerides SL, 12 x 20 mL, REF TGML-0250-NA ENVOY 500 Cholesterol Reagent Kit, REF 55297 Cholesterol SL, 12 x 20 mL, REF CHSL-0250-NA ALT/GPT 4+1 SL, 8 x 25 mL, REF ALSL-0250-NA ENVOY 500 ALT Reagent Kit, REF 55215 GAMMA-GT SZASZ SL, REF GZSL-0250 ENVOY 500 GGT Reagent Kit, REF 55352 ENVOY 500 AST Reagent Kit, REF 55255 ENVOY 500 AST Reagent Kit, REF 55250 Uric Acid Mono SL, 12 x 20 mL, REF AUML-0250-NA Urea UV SL, 8 x 25 mL, REF URSL-0250-NA ENVOY 500 BUN Reagent Kit, REF 55445 ENVOY 500 Phosphorus Reagent Kit, REF 55415 Phosphorus, 6 x 20 mL, REF PHOS-0230-NA Bypass Electrode Selectra Envoy Reference Electrode Envoy Bypass Electrode Reference Electrode Selectra ELITROL II, 10 x 5 mL : reference CONT-0180 ELITROL I , 10 x 5 mL : reference CONT-0080 ELITROL II, 10 x 5 mL : reference CONT-0160 ELITROL I , 10 x 5 mL : reference CONT-0060 Envoy 500 Wash Solution Kit, ref.55152 Envoy ISE Cleaner System Solution ENVOY500 ISE REFERENCE SOLUTION KIT Envoy Rinse Solution Kit ISE DILUENT 12 X 25 mL Acid Solution System Cleaning Solution Envoy Rinse Solution Bulk Kit Envoy 500 Wash Solution Kit , ref.55158 ENVOY500 ISE BASELINE SOLUTION KIT Envoy Rinse Solution Envoy ISE Conditioner ISE REFERENCE SOLUTION, 1 X 500 mL SYSTEM SOLUTION For Viva Drug Testing Systems ISE CLEANER/CONDITIONER, Ref. ISCC-0280 ENVOY500 ISE DILUENT KIT GLUCOSE HK SL, Ref.GHSL-0250 CK NAC SL, 4 x 25 mL, REF CKSL-0230-NA ENVOY 500 Amylase Reagent Kit, REF 55245 Amylase SL, 6 x 20 mL, REF AMSL-0230-NA ENVOY 500 Serum Control Kit, REF 55131 AST/GOT 4+1 SL, Ref.ASSL-0250 ENVOY 500 Total Bilirubin Reagent Kit, REF 55270 ENVOY 500 Direct Bilirubin Reagent Kit, REF 55260 ENVOY 500 LDH Reagent Kit, REF 55395 LDH-L SL, 4 x 25, REF LLSL-0230-NA ISE Calibrators, REF ISCA-0250 Selectra Pro ISE CO2 Electrode Total Protein Plus, 12 x 20mL, REF PROB-0250-NA ENVOY 500 Total Protein Reagent Kit, REF 55425 ENVOY 500 HDL Calibrator Kit, REF 55119 ENVOY 500 HDL Cholesterol Reagent Kit, REF 55301 Envoy 500 Serum Calibrator Kit, REF 55111 Envoy 500 Calcium Reagent Kit, REF 55287 Calcium Arsenazo, 12 x 20 mL, REF CALA-0250-NA ENVOY 500 Uric Acid Reagent Kit, REF 55450 ENVOY 500 LDL Cholesterol Reagent Kit, REF 55310 ENVOY 500 LDL Calibrator Kit, REF 55115 HbA1c Calibrator Set, 4 x 0.5 mL, REF HBAC-0043 HbA1c Control L + H, 4 x 0.5 mL, REF HBAC-0049 HbA1c Control L + H, 4 x 0.5 mL, REF HBAC-0049-NA HbA1c, 1 x 32 mL, REF HBAC-0240-NA HbA1c Calibrator Set, 4 x 0.5 mL, REF HBAC-0043-NA Iron Ferene, 4 x 18.5 mL, REF FEFE-0230-NA ENVOY 500 Iron Reagent Kit, REF 55360 Albumin, 12 x 20 mL, REF ALBU-0250-NA ENVOY 500 Albumin Reagent Kit, REF 55225 CALCIUM ARSENAZO, Ref.CALA-0250 ENVOY 500 ALP Reagent Kit, REF 55230 ENVOY 500 Magnesium Reagent Kit, REF 55400 MAGNESIUM XYLIDYL, 8 x 8.8 mL, REF MAGX-0230-NA ELICAL 2, 4 X 3 mL. Reference CALI-0580 ELICAL 2, 4 X 3 mL. Reference CALI-0550 Direct A1c Calibrator Kit Direct A1c Reagent Set Direct A1c Control Kit Bilirubin Direct 4+1, 8 x 25 mL, REF BIDI-0250-NA Bilirubin Total 4+1, 8 x 25 mL, REF BITO-0250-NA ENVOY 500 Creatinine Reagent Kit, REF 55335 ENVOY 500 Glucose Reagent Kit, REF 55345 Glucose PAP SL, 12 x 20 mL, REF GPSL-0250-NA Chloride Electrode, REF 280-001 Sodium Electrode, REF 278-001 Potassium Electrode, REF 279-001 ENVOY500 ISE CALIBRATOR KIT, Ref 55117 Carbon Dioxide Electrode, 275-001 Selectra Pro Sodium Electrode ISE REFERENCE, Ref. ISRS-0800 Selectra Pro Chloride Electrode AST/GOT 4+1 SL ISE DILUENT, Ref. ISDI-0250 Selectra Pro Potassium Electrode Envoy 500 CK Reagent Kit, REF 55327 BILIRUBIN TOTAL 4+1, REF BITO-0250 BILIRUBIN DIRECT 4+1, REF BIDI-0250 ISE Control I, 10 x 5 mL, REF ISCT-0046

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device