Dirui Industrial Co., Ltd.
Registered establishment in Changchun, Jilin, China. 84 device types, 1 clearance.
Dirui Industrial Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Detergent, Apolipoproteins and 82 other device types. Its earliest product listing with the FDA dates from 2002.
84device types registered with the FDA
1510(k) clearance
Registration
| Registered name | DIRUI INDUSTRIAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003741796 |
| FEI number | 3003741796 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Private-label distributor, Manufacturer |
Chinese Registration
| Chinese legal name | 迪瑞医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91220101605902656F |
| Source | NMPA UDI database |
Location
| City | Changchun |
|---|---|
| Province | Jilin |
| Address | 95 YUNHE ST., NEW & HIGH TECH |
| Postal code | 130012 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| 25-Oh-Vitamin D Mass Spectrometry Test System | Class 2 | 25-Hydroxyvitamin D Detection Kit(Chemiluminescence Immunoassay) | 2023 | 1 |
| 5-Amp-Phosphate Release (Colorimetric Test), 5′-Nucleotidase | Class 1 | 5?-NUCLEOTIDASE Reagent KIT | 2023 | 2 |
| Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | Class 1 | ? -Hydroxybutyric Dehydrogenase Reagent KIT | 2023 | 2 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Class 1 | Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips, Dirui Urine Analyzer, Dirui and 1 more | 2003 | 10 |
| Acid, Uric, Uricase (Colorimetric) | Class 1 | Uric Acid Reagent KIT | 2023 | 6 |
| Albumin, Antigen, Antiserum, Control | Class 2 | Microalbumin Reagent KIT | 2023 | 2 |
| Alkaline Phosphatase | Class 1 | Alkaline Phosphatase Reagent KIT | 2023 | 1 |
| Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control | Class 1 | Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay) | 2023 | 1 |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | Class 1 | ?1-Microglobulin Reagent Kit | 2023 | 3 |
| Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | Class 1 | ?1-acid Glycoprotein Reagent Kit (Immunoturbidimetric Assay), | 2023 | 2 |
| Alpha-2-Macroglobulin, Antigen, Antiserum, Control | Class 2 | ?2-macroglobulin Reagent Kit (Immunoturbidimetric Assay) | 2023 | 2 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class 1 | Dirui CS-1300/CAROLINA Liquid Chemistries CLC 1600 Chemistry Analyzer, Dirui CS-400/CAROLINA Liquid Chemistries CLC800 Chemistry Analyzer, Dirui CS-6400/CAROLINA Liquid Chemistries CLC 6410 Chemistry Analyzer, CS Series Chemistry Analyzer, Various names and models, DIRUI CS-480 Auto-Chemistry Analyzer, DIRUI CS-1600 Auto-Chemistry Analyzer and 5 more | 2012 | 16 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | Class 1 | Auto-Chemistry Analyzer (CS-2000, CS-2000i); Integrated System (CSM-8000) | 2023 | 9 |
| Antistreptolysin – Titer/Streptolysin O Reagent | Class 1 | Anti-Streptolysin O KIT | 2023 | 3 |
| Apolipoproteins | Class 1 | APOLIPOPROTEIN B REAGENT KIT, Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay),, Apolipoprotein C3 Reagent Kit (Immunoturbidimetric Assay), Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay), APOLIPOPROTEIN A1 REAGENT KIT, Apolipoprotein A2 Reagent Kit (Immunoturbidimetric Assay), | 2023 | 2 |
| Atp And Creatine Kinase (Enzymatic), Creatine | Class 1 | Creatine Kinase Reagent KIT (Ifcc Method) | 2023 | 1 |
| Automated Urinalysis System | Class 1 | Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips, Dirui Urine Analyzer, DIRUI URINE ANALYZER, DIRUI MUS-3600 Urinalysis System,DIRUI H-1600 Urine Analyzer, DIRUI HC-300 Urine Analyzer, and 2 more | 2002 | 16 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class 1 | Dirui | 2003 | 12 |
| Bathophenanthroline, Colorimetry, Iron (Non-Heme) | Class 1 | FE Reagent KIT | 2023 | 2 |
| Biuret (Colorimetric), Total Protein | Class 2 | Total Protein Reagent KIT | 2023 | 3 |
| Blood, Occult, Colorimetric, In Urine | Class 2 | Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips, Dirui Urine Analyzer | 2007 | 5 |
| Calibrator For Cell Indices | Class 2 | Calibrator for Automatic Hematology Analyzer; Fluorescent Calibrator | 2023 | 3 |
| Calibrator For Hemoglobin And Hematocrit Measurement | Class 2 | Calibrator for Automatic Hematology Analyzer; Fluorescent Calibrator | 2023 | 2 |
| Calibrator For Platelet Counting | Class 2 | Calibrator for Automatic Hematology Analyzer; Fluorescent Calibrator | 2023 | 2 |
| Calibrator For Red-Cell And White-Cell Counting | Class 2 | Calibrator for Automatic Hematology Analyzer; Fluorescent Calibrator | 2023 | 2 |
| Calibrator, Multi-Analyte Mixture | Class 2 | Clinical Chemical Calibration Serum, Clinical Chemical Quality Control Serum, ISE blood sample calibrator, ISE Urine Calibrator, ISE Urine Control, Specific Protein Control Serum | 2023 | 3 |
| Cholinesterase Test Paper | Class 1 | Cholinesterase Reagent KIT | 2023 | 1 |
| Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | Class 2 | Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay ) | 2023 | 1 |
| Chromatographic, Phospholipids | Class 1 | Phospholipid Reagent Kit (Choline Oxide Assay) | 2023 | 1 |
| Chromogenesis, Phenylketones (Urinary, Non-Quant.) | Class 1 | DIRUI KETONE Reagent Strips for Urinalysis | 2023 | 1 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | Class 1 | Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips, Dirui Urine Analyzer | 2007 | 13 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | Class 1 | ?- Glutamyl Transferase Reagent KIT | 2023 | 2 |
| Container, Specimen, Sterile | Class 1 | Disposable Urine Tube | 2023 | 79 |
| Detergent | Class 1 | CS-Anti-Bacterial phosphor-Free Detergent, CS-Alkaline Detergent, ISE Diluent, CS-ISE Detergent | 2022 | 5 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips, Dirui Urine Analyzer, Dirui H11, Dirui H10, Dirui H8 and 1 more | 2003 | 14 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Class 1 | Dirui H11, Dirui H8, Dirui H10, Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips and 2 more | 2003 | 11 |
| Diethyldithiocarbamate (Colorimetric), Copper | Class 1 | Copper Reagent Kit(PAESA Chromogenic Agent Assay) | 2023 | 2 |
| Disinfectant, Medical Devices | Class 1 | H Series Urine Analyzer Cleaning Lliquid for Refractometer and Turbidimeter, Probe Conditioning Solution,, Probe Washing Buffer, RBC Folate Releasing Agent, Urine Sediment Analyzer Detergent, Cleaning Liquid II (Concentrated type), Cleaning liquid(concentrated type), Concentreated Washing Buffer, | 2023 | 197 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | Dirui H11, Dirui H10, Dirui H8, Dirui, Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips and 1 more | 2003 | 16 |
| Electrolyte Controls (Assayed And Unassayed) | Class 1 | Urine Conductivity Analysis Calibrator, Urine Conductivity Analysis Control | 2023 | 3 |
| Enzymatic (Glutathione Reductase), Glutathione | Class 1 | Glutathione Reductase Reagent Kit (Glutathione Substrate Assay) | 2023 | 2 |
| Enzyme Immunoassay, Inhibin-A | Class 1 | Inhibin B Detection Kit (Chemiluminescence Immunoassay) | 2023 | 2 |
| Ferrozine (Colorimetric) Iron Binding Capacity | Class 1 | Total Iron-Binding Capacity Reagent Kit | 2023 | 2 |
| General Purpose Reagent | Class 1 | ISE Internal standard Solution, ISE Reference Solution, ISE Standard Solution (HIGH), ISE Standard Solution (LOW), Reference Liquid for Auto-Chemistry Analyzer, Sample Diluent, Sample Pretreatment Reagent, Sheath, Internal Standard Liquid for Auto-Chemistry Analyzer, ISE Diluent, ISE Internal Standard Liquid II,, Urine Sediment Analyzer Reagent Diluent, Urine Sediment Analyzer Reagent Sheath, Acid Trigger Reagent, Alkaline Trigger Reagent, FUS Series Urinalysis Hybrid Sheath II, | 2023 | 30 |
| Haptoglobin, Antigen, Antiserum, Control | Class 2 | HAPTOGLOBIN REAGENT KIT, Haptoglobin Reagent Kit (Immunoturbidimetric Assay) | 2023 | 2 |
| Immunohistochemistry Reagents And Kits | Class 1 | ADENOSINE DEAMINASE REAGENT KIT, Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay),, ?-L-Fucosidase Reagent Kit (CNPF Substrate Method), Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay), | 2023 | 7 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class 1 | Dirui H11, Dirui H10, Dirui H8, Dirui, Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips and 1 more | 2003 | 14 |
| Indirect Copper Assay, Ceruloplasmin | Class 2 | Ceruloplasmin Reagent Kit (Immunoturbidimetric Assay) | 2023 | 1 |
| L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase | Class 1 | Isocitrate Dehydrogenase Reagent KIT | 2023 | 1 |
| L-Leucyl B-Naphthylamide, Leucine Aminopeptidase | Class 1 | Leucine Aminopeptidase Reagent KIT | 2023 | 1 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | Class 1 | Lipase Reagent Kit, LIPASE REAGENT KIT (COLORIMETRIC METHOD) | 2023 | 2 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Class 2 | Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips, Dirui Urine Analyzer | 2007 | 5 |
| Mixture, Control, White-Cell And Red-Cell Indices | Class 2 | Control for Body Liquid (Level 2); Control for Body Liquid (Level 1) | 2023 | 1 |
| Mixture, Hematology Quality Control | Class 2 | Control for Automatic Hematology Analyzer (3-Part Level 1); Control for Automatic Hematology Analyzer (5-Part Level 1);, Fluorescent Control (Level 2); Fluorescent Control (Level 1); Fluorescent Control (Level 3);, Control for Automatic Hematology Analyzer (5-Part Level 2); Control for Automatic Hematology Analyzer (5-Part Level 3);, Control for Reticulocyte (Level 1); Control for Reticulocyte (Level 2); Control for Reticulocyte (Level 3), Control for Automatic Hematology Analyzer (3-Part Level 3); Control for Automatic Hematology Analyzer (3-Part Level 2); | 2023 | 3 |
| Multi-Analyte Controls Unassayed | Class 1 | Urinalysis Multi-Control, Multi-Calibrator for Urine Physical and Chemical Analysis, Multi-Control for Urine Physical and Chemical Analysis, | 2023 | 2 |
| N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | Class 1 | N-acetyl-?-D-Glucosaminidase Reagent Kit | 2023 | 2 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | Class 2 | Lactate Reagent Kit(Lactate Oxidase Based Method), LACTATE DEHYDROGENASE REAGENT KIT | 2023 | 2 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | Class 1 | Alanine Aminotransferase Liquid KIT | 2023 | 3 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | Class 2 | ASPARTATE AMINOTRANSFERASE REAGENT KIT, Mitochondrial Aspartate Aminotransferase Reagent Kit(Immunoinhibition) | 2023 | 2 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | Ketogen, Dirui, KETOGEN, DIRUI, Dirui H11, Dirui H10, Dirui H8, ?-Hydroxybutyrate Reagent Kit (?-hydroxybutyric Dehydrogenase Assay), Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips and 2 more | 2002 | 17 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | Class 1 | Inorganic Phosphorus Reagent KIT | 2023 | 2 |
| Prealbumin, Antigen, Antiserum, Control | Class 1 | Prealbumin Reagent KIT | 2023 | 3 |
| Radioimmunoassay, 17-Hydroxyprogesterone | Class 1 | 17?-Hydroxyprogesterone Detection Kit Detection Kit (Chemiluminescence Immunoassay) | 2023 | 1 |
| Radioimmunoassay, C-Peptides Of Proinsulin | Class 1 | C-Peptide Detection Kit | 2023 | 6 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | Class 1 | Dehydroepiandrosterone Detection Kit (Chemiluminescence Immunoassay) | 2023 | 3 |
| Radioimmunoassay, Estradiol | Class 1 | Estradiol Detection Kit | 2023 | 5 |
| Radioimmunoassay, Follicle-Stimulating Hormone | Class 1 | Follicle Stimulating Hormone Detection Kit | 2023 | 6 |
| Radioimmunoassay, Human Growth Hormone | Class 1 | Human Growth Hormone Detection Kit(Chemiluminescence Immunoassay) | 2023 | 5 |
| Radioimmunoassay, Immunoreactive Insulin | Class 1 | Insulin Detection Kit | 2023 | 4 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | Luteinizing Hormone Detection Kit | 2023 | 16 |
| Radioimmunoassay, Prolactin (Lactogen) | Class 1 | Prolactin Detection Kit | 2023 | 6 |
| Radioimmunoassay, Thyroxine-Binding Globulin | Class 2 | Thyroglobulin Detection Kit | 2023 | 2 |
| Radioimmunoassay, Total Thyroxine | Class 2 | Thyroxine Detection Kit | 2023 | 5 |
| Radioimmunoassay, Total Triiodothyronine | Class 2 | Triiodothyronine Detection Kit | 2023 | 5 |
| Refractometer For Clinical Use | Class 1 | Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips, Dirui Urine Analyzer, Dirui H11, Dirui H10, Dirui H8 and 1 more | 2003 | 8 |
| Retinol-Binding Protein, Antigen, Antiserum, Control | Class 1 | Retinol Binding Protein (RBP) Reagent Kit (Latex Immunoturbidimetric Assay), Retinol-binding Protein Reagent Kit, Pyruvate Reagent Kit (Lactate Dehydrogenase Assay), | 2023 | 3 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | Class 1 | Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method), HOMOCYSTEINE REAGENT KIT | 2023 | 12 |
| Sulfophosphovanillin, Colorimetry, Total Lipids | Class 1 | Lipid Control Serum | 2023 | 1 |
| System, Test, Beta-2-Microglobulin Immunological | Class 2 | ?2-Microglobulin Detection Kit(Chemiluminescence Immunoassay) | 2023 | 3 |
| System, Test, Lipoprotein(A) | Class 1 | LIPOPROTEIN (a) REAGENT KIT | 2023 | 2 |
| Test, Urine Leukocyte | Class 1 | Dirui Muiltiple Reagent Strips, Ketogen Ketone Test Strips, Uristik H Series Reagent Strips, URS 10 parameter strips, Dirui Urine Analyzer, DIRUI, Dirui H11, Dirui H10, Dirui H8, DIRUI PROTEIN Reagent Strips for Urinalysis | 2003 | 16 |
| Titrimetric, Fatty Acids | Class 1 | Free Fatty Acid Reagetn Kit(ACS-ACOD Assay),, Heart Fatty Acid-Binding Protein Reagent Kit(Latex Immunoturbidimetric Assay) | 2023 | 2 |
| Turbidimetric, Total Protein | Class 2 | Total Protein in Urine Reagent Kit (Turbidimetric Method) | 2023 | 1 |
| Urinalysis Controls (Assayed And Unassayed) | Class 1 | FE Control II Positive Control, H series urine analyzer Calibration liquid for Turbidity,, H series urine analyzer Color Control, H series urine analyzer Control liquid for Specific gravity,, FE Calibrator, FE Calibrator II, FE Control FE Control II Negative Control, FE Control II Positive Control,, H series urine analyzer Control liquid for Turbidity, Urinalysis Control | 2023 | 3 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K040703 | 2004-08-26 | JIO | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1992 |
|---|---|
| Main products | biochemistry analyzers, urinalysis analyzers, immunoassay analyzers, hematology analyzers, coagulation analyzers |
| Certifications | FDA, CE |
| Export markets | over 100 countries |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Changchun Wancheng BIO-Electron Co., Ltd. | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | 24 |
| Changchun LYZ Technology Co., Ltd. | 16 |
| Jilin Test BIO-Electron Co., Ltd. | 9 |
| Sincera Technology (Changchun) Co., Ltd. | 2 |
| Sino-Dentex Co., Ltd. | 2 |
| Changchun AIK Medical Devices Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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