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Data / Medical devices / China / Dirui Industrial Co., Ltd.

Dirui Industrial Co., Ltd.: FDA-registered device maker in CHANGCHUN Jilin, China, 1 510(k) clearance

Dirui Industrial Co., Ltd. is registered with the FDA (registration 3003741796) in CHANGCHUN Jilin, China. It lists 84 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 26, 2004. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Dirui Industrial Co., Ltd.
FDA registration number
3003741796
Address
95 Yunhe ST., New & High Tech Development Zone, CHANGCHUN Jilin, China, 130012
Owner or operator
DIRUI INDUSTRIAL CO., LTD. (9049667)
Roles
Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed
February 7, 2002
Registered through
2026
Brand names listed
17?-Hydroxyprogesterone Detection Kit Detection Kit (Chemiluminescence Immunoassay), 25-Hydroxyvitamin D Detection Kit(Chemiluminescence Immunoassay), 5?-NUCLEOTIDASE REAGENT KIT, ? -HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT, ?- GLUTAMYL TRANSFERASE REAGENT KIT, ?-L-Fucosidase Reagent Kit (CNPF Substrate Method), ?1-Microglobulin Reagent Kit, ?1-acid Glycoprotein Reagent Kit (Immunoturbidimetric Assay) and more

Devices it lists

DeviceProduct codeClassRoleSource
25-Oh-Vitamin D Mass Spectrometry Test SystemPSL2Manufactureraccessdata.fda.gov
5-Amp-Phosphate Release (Colorimetric Test), 5'-NucleotidaseCED1Manufactureraccessdata.fda.gov
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric DehydrogenaseJMK1Manufactureraccessdata.fda.gov
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Manufactureraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Manufactureraccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Manufactureraccessdata.fda.gov
Alkaline PhosphataseJCJ1Manufactureraccessdata.fda.gov
Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, ControlDBC1Manufactureraccessdata.fda.gov
Alpha-1 Microglobulin, Antigen, Antiserum, ControlMGA1Manufactureraccessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlLKL1Manufactureraccessdata.fda.gov
Alpha-2-Macroglobulin, Antigen, Antiserum, ControlDEB2Manufactureraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Contract manufacturer, Manufactureraccessdata.fda.gov
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical UseJJC1Manufactureraccessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O ReagentGTQ1Manufactureraccessdata.fda.gov
ApolipoproteinsMSJ1Manufactureraccessdata.fda.gov
Atp And Creatine Kinase (Enzymatic), CreatineJLB1Manufactureraccessdata.fda.gov
Automated Urinalysis SystemKQO1Contract manufacturer, Manufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Contract manufacturer, Manufactureraccessdata.fda.gov
Bathophenanthroline, Colorimetry, Iron (Non-Heme)CFM1Manufactureraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Manufactureraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Contract manufacturer, Manufactureraccessdata.fda.gov
Calibrator For Cell IndicesKRX2Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit MeasurementKRZ2Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Calibrator For Platelet CountingKRY2Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Calibrator For Red-Cell And White-Cell CountingKSA2Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufactureraccessdata.fda.gov
Cholinesterase Test PaperDIG1Manufactureraccessdata.fda.gov
Chromatographic Separation, Lactate Dehydrogenase IsoenzymesCEX2Manufactureraccessdata.fda.gov
Chromatographic, PhospholipidsJNT1Manufactureraccessdata.fda.gov
Chromogenesis, Phenylketones (Urinary, Non-Quant.)CES1Manufactureraccessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1Manufactureraccessdata.fda.gov
Colorimetric Method, Gamma-Glutamyl TranspeptidaseJPZ1Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufactureraccessdata.fda.gov
DetergentJCB1Manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Contract manufacturer, Manufactureraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Contract manufacturer, Manufactureraccessdata.fda.gov
Diethyldithiocarbamate (Colorimetric), CopperJKZ1Manufactureraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Contract manufacturer, Manufactureraccessdata.fda.gov
Electrolyte Controls (Assayed And Unassayed)JJR1Manufactureraccessdata.fda.gov
Enzymatic (Glutathione Reductase), GlutathioneJLO1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Inhibin-ANDR1Manufactureraccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Manufactureraccessdata.fda.gov
Haptoglobin, Antigen, Antiserum, ControlDAD2Manufactureraccessdata.fda.gov
Immunohistochemistry Reagents And KitsNJT1Manufactureraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Contract manufacturer, Manufactureraccessdata.fda.gov
Indirect Copper Assay, CeruloplasminJFR2Manufactureraccessdata.fda.gov
L-Isocitrate And Nadp (U.V.), Isocitric DehydrogenaseJKG1Manufactureraccessdata.fda.gov
L-Leucyl B-Naphthylamide, Leucine AminopeptidaseCDC1Manufactureraccessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, LipaseCHI1Manufactureraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Contract manufacturer, Manufactureraccessdata.fda.gov
Mixture, Control, White-Cell And Red-Cell IndicesGLQ2Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Mixture, Hematology Quality ControlJPK2Foreign private label distributor, Repackager or relabeleraccessdata.fda.gov
Multi-Analyte Controls UnassayedOHQ1Manufactureraccessdata.fda.gov
N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), ChymotrypsinJKW1Manufactureraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Contract manufacturer, Manufactureraccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Manufactureraccessdata.fda.gov
Prealbumin, Antigen, Antiserum, ControlJZJ1Manufactureraccessdata.fda.gov
Radioimmunoassay, 17-HydroxyprogesteroneJLX1Manufactureraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Manufactureraccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Manufactureraccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Manufactureraccessdata.fda.gov
Radioimmunoassay, Human Growth HormoneCFL1Manufactureraccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Manufactureraccessdata.fda.gov
Radioimmunoassay, Thyroxine-Binding GlobulinCEE2Manufactureraccessdata.fda.gov
Radioimmunoassay, Total ThyroxineCDX2Manufactureraccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Manufactureraccessdata.fda.gov
Refractometer For Clinical UseJRE1Manufactureraccessdata.fda.gov
Retinol-Binding Protein, Antigen, Antiserum, ControlCZS1Manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufactureraccessdata.fda.gov
Sulfophosphovanillin, Colorimetry, Total LipidsCFD1Manufactureraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Manufactureraccessdata.fda.gov
System, Test, Lipoprotein(A)MSM1Manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Contract manufacturer, Manufactureraccessdata.fda.gov
Titrimetric, Fatty AcidsJLH1Manufactureraccessdata.fda.gov
Turbidimetric, Total ProteinJGQ2Manufactureraccessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)JJW1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 26, 2004K040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSISJIOSubstantially EquivalentDirui Industrial Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 26, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.