Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003741796

FEI Number

3003741796

Entity Name

DIRUI INDUSTRIAL CO., LTD.

City/State/Country

CHANGCHUN Jilin, CN

Establishment Address

95 YUNHE ST., NEW & HIGH TECH, DEVELOPMENT ZONE, CHANGCHUN Jilin 130012, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIRUI INDUSTRIAL CO., LTD. (Owner Number: 9049667)

Owner / Operator Contact Address

95 YUNHE ST.,NEW & HIGH TECH., DEVELOPMENT ZONE, CHANGCHUN, CN-JL 130012, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Dirui H11, Dirui H10, Dirui H8 DIRUI DIRUI 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 H11, Dirui H10, Dirui H8 DIRUI 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) DIRUI 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) Dirui H11, Dirui H10, Dirui H8 DIRUI Calibrator for Automatic Hematology Analyzer; Fluorescent Calibrator 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 Calibrator for Automatic Hematology Analyzer; Fluorescent Calibrator 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2023-02-21
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2003-01-15
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2023-02-21
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2023-02-21
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2003-01-15
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2023-02-21
MSM	System, Test, Lipoprotein(A)	Clinical Chemistry	Class 1	862.1475	2023-02-21
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2003-01-15
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2003-01-15
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2023-02-21
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2023-02-21
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2013-06-26
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2013-06-26
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2013-06-26
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2013-06-26
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2013-06-26
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2013-06-26
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2013-06-26
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2013-06-26
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2013-06-26
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2013-06-26
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2023-02-21
DBC	Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5425	2023-02-21
MGA	Alpha-1 Microglobulin, Antigen, Antiserum, Control	Immunology	Class 1	866.5400	2023-02-21
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2023-08-04
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2002-08-13
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2003-01-15
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-05-27
CDX	Radioimmunoassay, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2023-02-21
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2023-02-21
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2023-02-21
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2023-08-04
CFM	Bathophenanthroline, Colorimetry, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2023-02-21
CED	5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase	Clinical Chemistry	Class 1	862.1520	2023-02-21
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2023-02-21
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2023-02-21
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-02-21
CEE	Radioimmunoassay, Thyroxine-Binding Globulin	Clinical Chemistry	Class 2	862.1685	2023-02-21
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2023-02-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2023-02-21
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2023-08-04
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2002-02-07
JFR	Indirect Copper Assay, Ceruloplasmin	Immunology	Class 2	866.5210	2023-02-21
NDR	Enzyme Immunoassay, Inhibin-A	Clinical Chemistry	Class 1	862.1260	2023-02-21
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2023-02-21
JJR	Electrolyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-02-21
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2023-02-21
JLH	Titrimetric, Fatty Acids	Clinical Chemistry	Class 1	862.1290	2023-02-21
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2023-02-21
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2023-02-21
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2023-02-21
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2023-02-21
CEX	Chromatographic Separation, Lactate Dehydrogenase Isoenzymes	Clinical Chemistry	Class 2	862.1445	2023-02-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-02-21
JLB	Atp And Creatine Kinase (Enzymatic), Creatine	Clinical Chemistry	Class 1	862.1210	2023-02-21
JKG	L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase	Clinical Chemistry	Class 1	862.1420	2023-02-21
JCB	Detergent	Pathology	Class 1	864.4010	2022-12-13
JLO	Enzymatic (Glutathione Reductase), Glutathione	Clinical Chemistry	Class 1	862.1365	2023-02-21
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2003-01-15
KRY	Calibrator For Platelet Counting	Hematology	Class 2	864.8175	2023-08-04
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2023-02-21
JCJ	Alkaline Phosphatase	Hematology	Class 1	864.7660	2023-02-21
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2023-02-21
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2023-02-21
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2023-02-21
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2023-02-21
JMK	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase	Clinical Chemistry	Class 1	862.1380	2023-02-21
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2023-08-04
PSL	25-Oh-Vitamin D Mass Spectrometry Test System	Clinical Chemistry	Class 2	862.1840	2023-02-21
CFD	Sulfophosphovanillin, Colorimetry, Total Lipids	Clinical Chemistry	Class 1	862.1470	2023-02-21
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2003-01-15
DIG	Cholinesterase Test Paper	Clinical Toxicology	Class 1	862.3240	2023-02-21

Official Correspondent

Christopher Patterson

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

DIRUI INDUSTRIAL CO., LTD.

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
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K781077	Dade, Baxter Travenol Diagnostics, Inc.	CONTROL, HEMATOLOGY, CH-60	1978-07-27
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K852783	Advanced Biomedical Methods, Inc.	SGOT/ALT REAGENT	1985-07-22

Related Recall Records

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Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003741796. Last updated year: 2026. Please use registration number 3003741796 when referencing this establishment in official correspondence.