Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014325803

FEI Number

3014325803

Entity Name

BIOBASE BIODUSTRY(SHANDONG)CO., LTD

City/State/Country

Jinan Shandong, CN

Establishment Address

Biobase Biological Industrial Park,Mingshui Economic Development Zone, Jinan Shandong 250200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biobase Biodustry(Shandong)Co., Ltd (Owner Number: 10056466)

Owner / Operator Contact Address

Biobase Biological Industrial Park,Mingshui Economic Development Zone, Jinan, CN-SD 250200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE Auto Cap Screwing Machine Automatic decapper Centrifuge BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE Electrolyte Analyzer BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE Dry bath incubator Medical centrifuge BIOBASE Vortex mixer Semi-auto Chemistry Analyzer Elisa Microplate Reader BIOBASE BIOBASE BIOBASE Water Purifier Ultrapure Water Purifier BIOBASE BIOBASE Real-time PCR instrument BIOBASE BIOBASE Disposabie Virus Sampling Collector Automatic Nucleic acid extration system Microplate washer BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE Auto ESR Analyzer Auto DESR Analyzer BIOBASE BIOBASE BIOBASE BIOBASE BIOBASE Specification Protein Analyzer BIOBASE BIOBASE BIOBASE Specimen Collection Swab

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2018-02-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-26
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-26
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2018-02-26
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-26
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2021-07-14
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2018-02-26
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-08-12
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	2025-12-19
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2021-07-14
JGF	Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes	Clinical Chemistry	Class 2	862.1445	2018-02-26
MGA	Alpha-1 Microglobulin, Antigen, Antiserum, Control	Immunology	Class 1	866.5400	2018-02-26
JHM	Colorimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2018-02-25
CED	5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase	Clinical Chemistry	Class 1	862.1520	2018-02-26
JMK	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase	Clinical Chemistry	Class 1	862.1380	2018-02-26
NDR	Enzyme Immunoassay, Inhibin-A	Clinical Chemistry	Class 1	862.1260	2021-07-14
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2018-02-25
JGG	L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase	Clinical Chemistry	Class 1	862.1460	2018-02-27
JGP	Lowry (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2018-02-27
JJP	Electrode, Ion Selective (Non-Specified)	Clinical Chemistry	Class 1	862.2050	2022-08-12
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2018-02-26
KQN	Radioassay, Angiotensin Converting Enzyme	Clinical Chemistry	Class 2	862.1090	2018-02-26
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2018-02-26
CFM	Bathophenanthroline, Colorimetry, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2018-02-26
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2018-02-26
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2022-03-30
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2021-07-14
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2021-07-14
CZS	Retinol-Binding Protein, Antigen, Antiserum, Control	Immunology	Class 1	866.5765	2018-02-26
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2021-07-14
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2021-07-14
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2018-02-26
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2018-02-26
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2018-02-25
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2022-08-12
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2021-07-14
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2021-07-12
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-01-04
NAO	Test, Carbohydrate Deficient Transferrin	Clinical Chemistry	Class 1	862.1360	2018-02-26
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2018-02-26
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2020-07-20
JTC	Device, Microtiter Diluting/Dispensing	Microbiology	Class 1	866.2500	2021-07-14
JZH	Factor B, Antigen, Antiserum, Control	Immunology	Class 2	866.5320	2018-02-26
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2018-02-22
CEL	Ammonium Molybdate And Ammonium Vanadate, Phospholipids	Clinical Chemistry	Class 1	862.1575	2018-02-26
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2018-02-26
JRM	Freezer	Clinical Chemistry	Class 1	862.2050	2018-08-28
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2018-02-26
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2018-02-25
GKB	Device, Automated Sedimentation Rate	Hematology	Class 1	864.5800	2022-08-12
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2021-07-14
JJN	Apparatus, Electrophoresis, For Clinical Use	Clinical Chemistry	Class 1	862.2485	2022-06-02
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2018-02-25
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2018-02-26
DDX	Plasminogen, Antigen, Antiserum, Control	Immunology	Class 1	866.5715	2018-02-26
JZW	Nephelometer	Immunology	Class 1	866.4540	2022-08-12
CGO	Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol	Clinical Chemistry	Class 1	862.1175	2018-02-27
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2021-07-14
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2018-02-26
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-12-16

Official Correspondent

Xiaofei Hu

US Agent Details

jie Lu Email: zhizaoyibuzhiliangtixiyu@bkkg1.wecom.work Phone: (650) 4506206

Related Public Records

Same Entity

Biobase Biodustry(Shandong)Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

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K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K830679	Dow Instruments & Reagents, Inc.	URIC ACID COLORIMETRIC DETERMINATION	1983-04-06
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26
K941042	Microgenics Corp.	CEDIA T4 MAB ASSAY	1994-04-26
K082638	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL	2009-02-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0089-2023	Siemens Healthcare Diagnostics, Inc.	1	Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Z-0006-2009	Roche Diagnostics Corp.	1	Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.

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3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014325803. Last updated year: 2026. Please use registration number 3014325803 when referencing this establishment in official correspondence.