VitalScientific

FDA Device Registration & Listing · SEES Normandie, FR · Registration 3007662974

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007662974
FEI Number
3007662974
Entity Name
VitalScientific
City/State/Country
SEES Normandie, FR
Establishment Address
Zone Industrielle, 13 rue Auguste Mottin, SEES Normandie 61500, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
VitalScientific (Owner Number: 10090892)
Owner / Operator Contact Address
13 Rue Auguste Mottin - Zone Industrielle, SEES, FR-61 61500, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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 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 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 ELITROL II, 10 x 5 mL, REF CONT-0180 ELITROL I, 10 x 5 mL, REF CONT-0080 ELICAL 2, 4 x 3 mL, REF CALI-0580 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 ELICAL 2, 4 x 3 mL, REF CALI-0580 ELITROL II, 10 x 5 mL, REF CONT-0180 CK NAC SL, 4 x 25 mL, REF CKSL-0230-NA ELITROL I, 10 x 5 mL, REF CONT-0080 ENVOY 500 Amylase Reagent Kit, REF 55245 Amylase SL, 6 x 20 mL, REF AMSL-0230-NA ELITROL I, 10 x 5 mL, REF CONT-0080 ELICAL 2, 4 x 3 mL, REF CALI-0580 ELITROL II, 10 x 5 mL, REF CONT-0180 ENVOY 500 Serum Control Kit, REF 55131 ELITROL II, 10 x 5 mL, REF CONT-0180 ELICAL 2, 4 x 3 mL, REF CALI-0580 AST/GOT 4+1 SL, Ref.ASSL-0250 ELITROL I, 10 x 5 mL, REF CONT-0080 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 ELITROL I, 10 x 5 mL, REF CONT-0080 Albumin, 12 x 20 mL, REF ALBU-0250-NA ELITROL II, 10 x 5 mL, REF CONT-0180 ELICAL 2, 4 x 3 mL, REF CALI-0580 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2024-05-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-31
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2024-05-31
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-05-31
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2024-06-25
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-06-25
CHI Lipase-Esterase, Enzymatic, Photometric, Lipase Clinical Chemistry Class 1 862.1465 2024-05-31
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2024-05-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-31
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2024-05-31
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2024-05-31
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-05-29
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-29
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2024-05-29
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2024-05-29
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2024-05-31
JQB Kinetic Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 2024-05-31
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2024-05-31
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2024-05-30
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2024-05-30
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-05-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-30
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2024-05-30
JJP Electrode, Ion Selective (Non-Specified) Clinical Chemistry Class 1 862.2050 2024-05-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2025-06-20
PPM General Purpose Reagent Pathology Class 1 864.4010 2024-05-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-31
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2024-05-31
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-05-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-31
JHW U.V. Method, Cpk Isoenzymes Clinical Chemistry Class 2 862.1215 2024-05-31
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-05-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-31
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2024-05-31
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-05-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-31
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2024-05-30
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-05-30
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2024-05-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2024-05-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2024-05-31
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2024-05-31
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2024-05-31
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2024-06-25
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-06-25
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2024-05-31
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2024-05-31
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2024-05-31
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-05-31
CJY Azo Dye, Calcium Clinical Chemistry Class 2 862.1145 2024-05-31
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2024-05-31
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2024-05-31
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2024-05-31
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2024-05-30
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2024-05-30
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-05-30
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2024-05-31
CJY Azo Dye, Calcium Clinical Chemistry Class 2 862.1145 2024-05-31
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2024-05-31
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2024-05-31
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2024-05-31
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2024-05-31
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2024-05-31

Official Correspondent

Valerie LAMBERT

US Agent Details

Junelle Goldson Business: Clinical Diagnostic Solutions, Inc Email: junelle.goldson@boule.com Phone: (954) 7911773

Related Public Records

Same Entity

VitalScientific
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04
K012065 Wiener Laboratories Saic WIENER LAB. CREATININA CINETICA AA 2001-10-10
K183555 Instrumentation Laboratory CO GEM Premier ChemSTAT 2019-02-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2015 ELITech Clinical Systems SAS Zone lndustrielle SEES France 2
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Z-0008-2009 Roche Diagnostics Corp. 2
Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of creatine in serum, urine and plasma.
Z-0164-2015 Siemens Healthcare Diagnostics, Inc 2
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015 Siemens Healthcare Diagnostics, Inc. 2
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007662974. Last updated year: 2026. Please use registration number 3007662974 when referencing this establishment in official correspondence.
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