FDA Registration
Active
🇨🇳 China
BIOBASE BIODUSTRY(SHANDONG)CO., LTD
Reg #: 3014325803
·
FEI: 3014325803
·
Expires 2026
Products
70
Proprietary Names
30
Establishment Types
1
Classifications
70
Registration Details
- Registration Name
- BIOBASE BIODUSTRY(SHANDONG)CO., LTD
- Registration Number
- 3014325803
- FEI Number
- 3014325803
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Biobase Biological Industrial Park,Mingshui Economic Development Zone
- City
- Jinan Shandong
- Country
- CN
Owner / Operator
- Firm Name
- Biobase Biodustry(Shandong)Co., Ltd
- Operator Number
- 10056466
- Address
- Biobase Biological Industrial Park,Mingshui Economic Development Zone
- City
- Jinan
- State
- Shandong
- Postal Code
- 250200
- Country
- CN
- Correspondent
- Xiaofei Hu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2018-02-25 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-26 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-26 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-26 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2021-07-14 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2022-08-12 |
| Centrifuge, Blood-Bank For In Vitro Diagnostic Use | KSO | Class 1 | Hematology | No | 2025-12-19 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | JGF | Class 2 | Clinical Chemistry | No | 2018-02-26 |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | MGA | Class 1 | Immunology | No | 2018-02-26 |
| Colorimetric Method, Lipoproteins | JHM | Class 1 | Clinical Chemistry | No | 2018-02-25 |
| 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase | CED | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | JMK | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Enzyme Immunoassay, Inhibin-A | NDR | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 2018-02-25 |
| L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase | JGG | Class 1 | Clinical Chemistry | No | 2018-02-27 |
| Lowry (Colorimetric), Total Protein | JGP | Class 2 | Clinical Chemistry | No | 2018-02-27 |
| Electrode, Ion Selective (Non-Specified) | JJP | Class 1 | Clinical Chemistry | No | 2022-08-12 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Radioassay, Angiotensin Converting Enzyme | KQN | Class 2 | Clinical Chemistry | No | 2018-02-26 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Bathophenanthroline, Colorimetry, Iron (Non-Heme) | CFM | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2022-03-30 |
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Retinol-Binding Protein, Antigen, Antiserum, Control | CZS | Class 1 | Immunology | No | 2018-02-26 |
| Shaker/Stirrer | JRQ | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2018-02-26 |
| Alpha-2-Macroglobulin, Antigen, Antiserum, Control | DEB | Class 2 | Immunology | No | 2018-02-26 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2018-02-25 |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | JRS | Class 1 | Clinical Chemistry | No | 2022-08-12 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2021-07-14 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 2021-07-12 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2022-01-04 |
| Test, Carbohydrate Deficient Transferrin | NAO | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2020-07-20 |
| Device, Microtiter Diluting/Dispensing | JTC | Class 1 | Microbiology | No | 2021-07-14 |
| Factor B, Antigen, Antiserum, Control | JZH | Class 2 | Immunology | No | 2018-02-26 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2018-02-22 |
| Ammonium Molybdate And Ammonium Vanadate, Phospholipids | CEL | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2018-02-26 |
| Freezer | JRM | Class 1 | Clinical Chemistry | No | 2018-08-28 |
| Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | LKL | Class 1 | Immunology | No | 2018-02-26 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2018-02-25 |
| Device, Automated Sedimentation Rate | GKB | Class 1 | Hematology | No | 2022-08-12 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Apparatus, Electrophoresis, For Clinical Use | JJN | Class 1 | Clinical Chemistry | No | 2022-06-02 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2018-02-25 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2018-02-26 |
| Plasminogen, Antigen, Antiserum, Control | DDX | Class 1 | Immunology | No | 2018-02-26 |
| Nephelometer | JZW | Class 1 | Immunology | No | 2022-08-12 |
| Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | CGO | Class 1 | Clinical Chemistry | No | 2018-02-27 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2018-02-26 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2021-12-16 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Diethyldithiocarbamate (Colorimetric), Copper | JKZ | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2018-02-26 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2018-02-26 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-04-11 |
| Reagent, Immunoassay, Igg | KTO | Class 1 | Immunology | No | 2018-02-26 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2022-08-12 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2018-02-26 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2018-02-25 |
Proprietary Names
BIOBASE
Auto Cap Screwing Machine
Automatic decapper
Centrifuge
Electrolyte Analyzer
Dry bath incubator
Medical centrifuge
Vortex mixer
Semi-auto Chemistry Analyzer
Elisa Microplate Reader
Water Purifier
Ultrapure Water Purifier
Real-time PCR instrument
Disposabie Virus Sampling Collector
Automatic Nucleic acid extration system
Microplate washer
Auto ESR Analyzer
Auto DESR Analyzer
Specification Protein Analyzer
Specimen Collection Swab
Automated Liquid Handler
Automated Sample Processing System
Automated ELISA Processor
Dry Chemistry Urine Analyzer
Automatic Chemistry Analyzer
Thermostatic Shaking Incubator
Thermostatic Water Tank
Medical Shaking Incubator
Table Top Shaker
Thermostatic Water Bath
Establishment Types
Manufacture Medical Device