FDA Registration
Active
🇨🇳 China
DIRUI INDUSTRIAL CO., LTD.
Reg #: 3003741796
·
FEI: 3003741796
·
Expires 2026
Products
84
Proprietary Names
116
Establishment Types
4
Classifications
84
Registration Details
- Registration Name
- DIRUI INDUSTRIAL CO., LTD.
- Registration Number
- 3003741796
- FEI Number
- 3003741796
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 95 YUNHE ST., NEW & HIGH TECH, DEVELOPMENT ZONE
- City
- CHANGCHUN Jilin
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K040703
Owner / Operator
- Firm Name
- DIRUI INDUSTRIAL CO., LTD.
- Operator Number
- 9049667
- Address
- 95 YUNHE ST.,NEW & HIGH TECH., DEVELOPMENT ZONE
- City
- CHANGCHUN
- State
- Jilin
- Postal Code
- 130012
- Country
- CN
- Correspondent
- Christopher M Patterson
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln., Suite 200
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2003-01-15 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2003-01-15 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| System, Test, Lipoprotein(A) | MSM | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2003-01-15 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2003-01-15 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2023-02-21 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2013-06-26 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2013-06-26 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2013-06-26 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2013-06-26 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control | DBC | Class 1 | Immunology | No | 2023-02-21 |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | MGA | Class 1 | Immunology | No | 2023-02-21 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2023-08-04 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2016-05-27 |
| Radioimmunoassay, Total Thyroxine | CDX | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Calibrator For Red-Cell And White-Cell Counting | KSA | Class 2 | Hematology | No | 2023-08-04 |
| Bathophenanthroline, Colorimetry, Iron (Non-Heme) | CFM | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase | CED | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2023-02-21 |
| Radioimmunoassay, Thyroxine-Binding Globulin | CEE | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | LKL | Class 1 | Immunology | No | 2023-02-21 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | JJC | Class 1 | Clinical Chemistry | No | 2023-08-04 |
| Indirect Copper Assay, Ceruloplasmin | JFR | Class 2 | Immunology | No | 2023-02-21 |
| Enzyme Immunoassay, Inhibin-A | NDR | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2023-02-21 |
| Electrolyte Controls (Assayed And Unassayed) | JJR | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Titrimetric, Fatty Acids | JLH | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2023-02-21 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2023-02-21 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | CEX | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Atp And Creatine Kinase (Enzymatic), Creatine | JLB | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase | JKG | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Detergent | JCB | Class 1 | Pathology | No | 2022-12-13 |
| Enzymatic (Glutathione Reductase), Glutathione | JLO | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Calibrator For Platelet Counting | KRY | Class 2 | Hematology | No | 2023-08-04 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Alkaline Phosphatase | JCJ | Class 1 | Hematology | No | 2023-02-21 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2023-02-21 |
| Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | JMK | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | Class 2 | Hematology | No | 2023-08-04 |
| 25-Oh-Vitamin D Mass Spectrometry Test System | PSL | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Sulfophosphovanillin, Colorimetry, Total Lipids | CFD | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Cholinesterase Test Paper | DIG | Class 1 | Clinical Toxicology | No | 2023-02-21 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2007-11-23 |
| L-Leucyl B-Naphthylamide, Leucine Aminopeptidase | CDC | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Calibrator For Cell Indices | KRX | Class 2 | Hematology | No | 2023-08-04 |
| Retinol-Binding Protein, Antigen, Antiserum, Control | CZS | Class 1 | Immunology | No | 2023-02-21 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2023-02-21 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Alpha-2-Macroglobulin, Antigen, Antiserum, Control | DEB | Class 2 | Immunology | No | 2023-02-21 |
| Diethyldithiocarbamate (Colorimetric), Copper | JKZ | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Turbidimetric, Total Protein | JGQ | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Chromogenesis, Phenylketones (Urinary, Non-Quant.) | CES | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | JKW | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2023-02-21 |
| Mixture, Control, White-Cell And Red-Cell Indices | GLQ | Class 2 | Hematology | No | 2023-08-04 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2023-02-21 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2023-02-21 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2023-02-21 |
| Chromatographic, Phospholipids | JNT | Class 1 | Clinical Chemistry | No | 2023-02-21 |
Proprietary Names
APOLIPOPROTEIN A1 REAGENT KIT, Apolipoprotein A2 Reagent Kit (Immunoturbidimetric Assay),
APOLIPOPROTEIN B REAGENT KIT, Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay),
Apolipoprotein C3 Reagent Kit (Immunoturbidimetric Assay), Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay)
Dirui H10
Dirui H8
DIRUI H11
C-Peptide Detection Kit
Estradiol Detection Kit
Dirui H11, Dirui H10, Dirui H8
DIRUI
Insulin Detection Kit
LIPOPROTEIN (a) REAGENT KIT
Lipase Reagent Kit, LIPASE REAGENT KIT (COLORIMETRIC METHOD)
MICROALBUMIN REAGENT KIT
ALANINE AMINOTRANSFERASE LIQUID KIT
Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay)
?1-Microglobulin Reagent Kit
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 Automatic Hematology Analyzer (3-Part Level 3); Control for Automatic Hematology Analyzer (3-Part Level 2);
Control for Reticulocyte (Level 1); Control for Reticulocyte (Level 2); Control for Reticulocyte (Level 3)
DIRUI URINE ANALYZER, DIRUI MUS-3600 Urinalysis System,DIRUI H-1600 Urine Analyzer, DIRUI HC-300 Urine Analyzer,
DIRUI FUS-3000Plus Urinalysis Hybrid, DIRUI FUS-2000 Urinalysis Hybrid, DIRUI FUS-1000 Urinalysis Hybrid,
DIRUI URINE ANALYZER, DIRUI, Dirui H11, Dirui H10, Dirui H8, DIRUI MUS-3600 Urinalysis System
DIRUI CS-6400/CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER
DIRUI CS-400/CAROLINA LIQUID CHEMISTRIES CLC800 CHEMISTRY ANALYZER
DIRUI CS-1300/CAROLINA LIQUID CHEMISTRIES CLC 1600 CHEMISTRY ANALYZER
Thyroxine Detection Kit
ASPARTATE AMINOTRANSFERASE REAGENT KIT, Mitochondrial Aspartate Aminotransferase Reagent Kit(Immunoinhibition)
Human Growth Hormone Detection Kit(Chemiluminescence Immunoassay)
Calibrator for Automatic Hematology Analyzer; Fluorescent Calibrator
FE REAGENT KIT
5?-NUCLEOTIDASE REAGENT KIT
TOTAL PROTEIN REAGENT KIT
Prolactin Detection Kit
Probe Washing Buffer, RBC Folate Releasing Agent, Urine Sediment Analyzer Detergent
H Series Urine Analyzer Cleaning Lliquid for Refractometer and Turbidimeter, Probe Conditioning Solution,
Cleaning Liquid II (Concentrated type), Cleaning liquid(concentrated type), Concentreated Washing Buffer,
Thyroglobulin Detection Kit
?1-acid Glycoprotein Reagent Kit (Immunoturbidimetric Assay)
?1-acid Glycoprotein Reagent Kit (Immunoturbidimetric Assay),
Clinical Chemical Calibration Serum, Clinical Chemical Quality Control Serum, ISE blood sample calibrator
ISE Urine Calibrator, ISE Urine Control, Specific Protein Control Serum
Auto-Chemistry Analyzer (CS-2000, CS-2000i); Integrated System (CSM-8000)
KETOGEN
KETOGEN, DIRUI, Dirui H11, Dirui H10, Dirui H8, ?-Hydroxybutyrate Reagent Kit (?-hydroxybutyric Dehydrogenase Assay)
Ceruloplasmin Reagent Kit (Immunoturbidimetric Assay)
Inhibin B Detection Kit (Chemiluminescence Immunoassay)
Disposable Urine Tube
Urine Conductivity Analysis Calibrator, Urine Conductivity Analysis Control
INORGANIC PHOSPHORUS REAGENT KIT
Free Fatty Acid Reagetn Kit(ACS-ACOD Assay),
Heart Fatty Acid-Binding Protein Reagent Kit(Latex Immunoturbidimetric Assay)
Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay),
ADENOSINE DEAMINASE REAGENT KIT, Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay),
?-L-Fucosidase Reagent Kit (CNPF Substrate Method)
HAPTOGLOBIN REAGENT KIT, Haptoglobin Reagent Kit (Immunoturbidimetric Assay)
Luteinizing Hormone Detection Kit
Total Iron-Binding Capacity Reagent Kit
Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay )
Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method), HOMOCYSTEINE REAGENT KIT
CREATINE KINASE REAGENT KIT (IFCC METHOD)
ISOCITRATE DEHYDROGENASE REAGENT KIT
CS-Anti-Bacterial phosphor-Free Detergent, CS-Alkaline Detergent, ISE Diluent, CS-ISE Detergent
Glutathione Reductase Reagent Kit (Glutathione Substrate Assay)
Dehydroepiandrosterone Detection Kit (Chemiluminescence Immunoassay)
ALKALINE PHOSPHATASE REAGENT KIT
URIC ACID REAGENT KIT
Triiodothyronine Detection Kit
Multi-Calibrator for Urine Physical and Chemical Analysis, Multi-Control for Urine Physical and Chemical Analysis,
Urinalysis Multi-Control
ANTI-STREPTOLYSIN O KIT
? -HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT
25-Hydroxyvitamin D Detection Kit(Chemiluminescence Immunoassay)
Lipid Control Serum
DIRUI, Dirui H11, Dirui H10, Dirui H8, DIRUI PROTEIN Reagent Strips for Urinalysis
CHOLINESTERASE REAGENT KIT
URISTIK H SERIES REAGENT STRIPS
DIRUI MUILTIPLE REAGENT STRIPS
KETOGEN KETONE TEST STRIPS
URS 10 parameter strips
DIRUI URINE ANALYZER
LEUCINE AMINOPEPTIDASE REAGENT KIT
Retinol Binding Protein (RBP) Reagent Kit (Latex Immunoturbidimetric Assay), Retinol-binding Protein Reagent Kit
Pyruvate Reagent Kit (Lactate Dehydrogenase Assay),
?2-Microglobulin Detection Kit(Chemiluminescence Immunoassay)
17?-Hydroxyprogesterone Detection Kit Detection Kit (Chemiluminescence Immunoassay)
?2-macroglobulin Reagent Kit (Immunoturbidimetric Assay)
Copper Reagent Kit(PAESA Chromogenic Agent Assay)
Total Protein in Urine Reagent Kit (Turbidimetric Method)
DIRUI KETONE Reagent Strips for Urinalysis
N-acetyl-?-D-Glucosaminidase Reagent Kit
Lactate Reagent Kit(Lactate Oxidase Based Method), LACTATE DEHYDROGENASE REAGENT KIT
Control for Body Liquid (Level 2); Control for Body Liquid (Level 1)
FE Calibrator, FE Calibrator II, FE Control FE Control II Negative Control, FE Control II Positive Control,
H series urine analyzer Color Control, H series urine analyzer Control liquid for Specific gravity,
FE Control II Positive Control, H series urine analyzer Calibration liquid for Turbidity,
H series urine analyzer Control liquid for Turbidity, Urinalysis Control
?- GLUTAMYL TRANSFERASE REAGENT KIT
PREALBUMIN REAGENT KIT
CS Series Chemistry Analyzer, Various names and models
DIRUI CS-T240Plus Auto-Chemistry Analyzer
DIRUI CS-680 Auto-Chemistry Analyzer
DIRUI CM-320 Chemiluminescence Immunoassay Analyzer
DIRUI CS-T180 Auto-Chemistry Analyzer
DIRUI CS-1600 Auto-Chemistry Analyzer
DIRUI CS-480 Auto-Chemistry Analyzer
DIRUI CM-180 Chemiluminescence Immunoassay Analyzer
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
Acid Trigger Reagent, Alkaline Trigger Reagent, FUS Series Urinalysis Hybrid Sheath II,
Internal Standard Liquid for Auto-Chemistry Analyzer, ISE Diluent, ISE Internal Standard Liquid II,
Urine Sediment Analyzer Reagent Diluent, Urine Sediment Analyzer Reagent Sheath
Follicle Stimulating Hormone Detection Kit
Phospholipid Reagent Kit (Choline Oxide Assay)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor
Repack or Relabel Medical Device