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Sign in to claim this brandBiobase Biodustry(Shandong) Co.,Ltd.
China·CN-MF-000025015
Last updated June 8, 2026
What Biobase Biodustry(Shandong) Co.,Ltd. makes
Biobase Biodustry(Shandong) Co.,Ltd. manufactures in vitro diagnostic (IVD) products including nucleic acid extraction/isolation kits using magnetic bead methods, general-purpose centrifuges, and reagents for clinical chemistry and immunoassay testing such as creatinine, calcium, bilirubin, sodium, iron, apolipoprotein B, D-dimer, microalbuminuria, and virus sampling tubes.
The company's devices are classified as Class A, Class I, and IVD General under regulatory frameworks and are listed in the EUDAMED database. Biobase Biodustry(Shandong) Co.,Ltd. is based in China (CN).
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Biobase Biodustry(Shandong) Co.,Ltd. make?
Biobase Biodustry(Shandong) Co.,Ltd. manufactures in vitro diagnostic (IVD) products such as nucleic acid extraction/isolation kits using magnetic bead methods, general-purpose centrifuges, and reagents for clinical chemistry and immunoassay testing. Examples include test kits for creatinine, calcium, bilirubin, sodium, iron, apolipoprotein B, D-dimer, microalbuminuria, and virus sampling tubes. These devices are designed for laboratory use in detecting biological markers.
Where is Biobase Biodustry(Shandong) Co.,Ltd. based?
Biobase Biodustry(Shandong) Co.,Ltd. is based in China, as indicated by the country code CN in the provided data. The company's manufacturing and operational activities are located within China, though specific city or facility details are not included in the source information.
Which regulatory registries list devices from Biobase Biodustry(Shandong) Co.,Ltd.?
Devices manufactured by Biobase Biodustry(Shandong) Co.,Ltd. are listed in the EUDAMED database, which is the European Union's system for tracking medical devices and IVDs. This listing indicates that the company's products have been registered for distribution in the EU market under applicable IVD regulations.
How are the devices from Biobase Biodustry(Shandong) Co.,Ltd. classified?
The devices produced by Biobase Biodustry(Shandong) Co.,Ltd. are classified as Class A, Class I, and IVD General under regulatory frameworks. These classifications reflect the risk level and intended use of the products, with Class A and IVD General typically applying to lower-risk in vitro diagnostic devices such as reagents and basic laboratory instruments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- Mingshui Economic Devlopment Zone, Zhangqiu Dsitrict, Jinan City, China
- Website
- biobase.cn
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- XuMeng Zhang
- EUDAMED SRN
- CN-MF-000025015
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (1003)
Page 18 of 21| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric) | R1:20mL×2 R2:20mL×2(713) | EUDAMED | IVD General | Active |
| Total Protein (TP) Test Kit (Biuret) | R:80mL×2（706） | EUDAMEDFDA UDI | IVD General | Active |
| Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method) | Quality Control：1mL×2(92061) | EUDAMED | IVD General | Active |
| Immune Globulin E (IgE) Test Kit (Immunoturbidimetric) | Quality Control：1mL×2（92040） | EUDAMED | IVD General | Active |
| C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric) | R1:20mL×1 R2:20mL×1(702) | EUDAMED | IVD General | Active |
| Lipase (LPS) Test Kit (Enzymatic Colorimetric) | R1:40mL×2 R2:20mL×2(713) | EUDAMEDFDA UDI | IVD General | Active |
| Lactate Dehydrogenase (LDH)Test Kit (DGKC) | R1:20mL×4 R2:5mL×4（796） | EUDAMEDFDA UDI | IVD General | Active |
| Albumin (ALB) Test Kit (BCG ) | R:80mL×2（706） | EUDAMED | IVD General | Active |
| Lactate Dehydrogenase (LDH)Test Kit (DGKC) | R1:48mL×2 R2:12mL×2（715） | EUDAMEDFDA UDI | IVD General | Active |
| Automatic Chemistry Analyzer | BS003 | EUDAMEDFDA UDI | Class A | Active |
| Retinol-binding Protein (RBP) Test Kit (Immunoturbidimetric) | Calibrator：1mL×1（91037） | EUDAMEDFDA UDI | IVD General | Active |
| Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) | R1:30mL×1 R2:10mL×1（704） | EUDAMED | IVD General | Active |
| Urea (UREA) Test Kit (Urease-GLDH) | R1:60mL×6 R2:60mL×2（795） | EUDAMED | IVD General | Active |
| Urinary Total Protein (UTP) Test Kit (Colorimetric) | R：70mL×2（700） | EUDAMEDFDA UDI | IVD General | Active |
| Microplate Washer | BS007 | EUDAMEDFDA UDI | Class I | Active |
| Glutamate Dehydrogenase (GLDH) Test Kit (Enzymatic) | R1:20mL×4 R2:5mL×4（709） | EUDAMED | IVD General | Active |
| Cholinesterase (CHE) Test Kit (Butyrylthiocholine ) | R1:40mL×4 R2:16mL×2（704） | EUDAMEDFDA UDI | IVD General | Active |
| Urea (UREA) Test Kit (Urease-GLDH) | R1:48mL×2 R2:32mL×1（792） | EUDAMED | IVD General | Active |
| Transferrin (TRF) Test Kit (Immunoturbidimetric) | R1:60mL×2 R2:20mL×2(701) | EUDAMEDFDA UDI | IVD General | Active |
| α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) | R1:48mL×2 R2:24mL×1（791） | EUDAMEDFDA UDI | IVD General | Active |
| Anti cyclic citrullinated peptide antibody (CCP) Test kit (Latex Immunoturbidimetric) | R1:18mL×4 R2:6mL×4（709） | EUDAMED | IVD General | Active |
| Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric) | R1:48mL×2 R2:12mL×2(705) | EUDAMEDFDA UDI | IVD General | Active |
| α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) | R1:48mL×2 R2:12mL×2（715） | EUDAMEDFDA UDI | IVD General | Active |
| α2 macroglobulin Assay Kit（Immunoturbidimetric） | R1:20mL×1 R2:4mL×1（702） | EUDAMEDFDA UDI | IVD General | Active |
| Albumin (ALB) Test Kit (BCG ) | R：120mL×1（703） | EUDAMED | IVD General | Active |
| Fibronectin (Fn) Test Kit (Immunoturbidimetric) | Calibrator：1mL×5（91049） | EUDAMED | IVD General | Active |
| Total Bilirubin (TBIL) Test Kit (DCA) | R1:50mL×2 R2:25mL×1（793） | EUDAMED | IVD General | Active |
| Lactate Dehydrogenase Isozyme 1 (LDH1) Test Kit (Lactate Stroma Rate) | R1:60mL×2 R2:12mL×2(701) | EUDAMEDFDA UDI | IVD General | Active |
| C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric) | R1:20mL×4 R2:20mL×4(709) | EUDAMED | IVD General | Active |
| Total Protein (TP) Test Kit (Biuret) | R:60mL×2（701） | EUDAMEDFDA UDI | IVD General | Active |
| Direct Bilirubin (DBIL) Test Kit (DCA) | R1:64mL×2 R2:16mL×2（701） | EUDAMED | IVD General | Active |
| Lactate Dehydrogenase Isozyme 1 (LDH1) Test Kit (Lactate Stroma Rate) | R1:50mL×2 R2:10mL×2(713) | EUDAMEDFDA UDI | IVD General | Active |
| Immune Globulin E (IgE) Test Kit (Immunoturbidimetric) | R1:20mL×1 R2:10mL×1（702） | EUDAMED | IVD General | Active |
| Total Protein (TP) Test Kit (Biuret) | R:40mL×4（704） | EUDAMEDFDA UDI | IVD General | Active |
| Chlorine (Cl-) Test Kit (Mercuric Thiocyanate) | R:20mL×8（709） | EUDAMED | IVD General | Active |
| Troponin I (TnI) Test Kit (Latex Enhanced Immunoturbidimetric) | R1:18mL×4 R2:6mL×4（709） | EUDAMED | IVD General | Active |
| α-Amylase (AMY) Test Kit (EPS-G7) | R1:50mL×1 R2:18mL×1（706） | EUDAMED | IVD General | Active |
| Semi-auto Chemistry Analyzer | BS002 | EUDAMEDFDA UDI | Class A | Active |
| Blood Coagulation Analyzer | BS011 | EUDAMED | Class A | Active |
| Automatic chemistry analyzer | Spin XL | EUDAMED | Class A | Active |
| Ischemia Modified Albumin (IMA) Test Kit(Colorimetric) | Quality Control：1mL×1（92029） | EUDAMED | IVD General | Active |
| Blood Coagulation Analyzer | BS011 | EUDAMED | Class A | Active |
| Cholinesterase (CHE) Test Kit (Butyrylthiocholine ) | R1:25mL×4 R2:5mL×4（709） | EUDAMEDFDA UDI | IVD General | Active |
| Procalcitonin (PCT) Test Kit (Latex Immunoturbidimetric) | R1:20mL×4 R2:5mL×4（709） | EUDAMED | IVD General | Active |
| Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method) | R1:60mL×5 R2:20mL×5(795) | EUDAMED | IVD General | Active |
| Total Bile Acid (TBA) Test Kit (Enzymatic Cycling) | R1:48mL×2 R2:16mL×2（705） | EUDAMED | IVD General | Active |
| "Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method)" | R1:48mL×2 R2:16mL×2(798) | EUDAMED | IVD General | Active |
| Automated Sample Processing System | BS004 | EUDAMEDFDA UDI | Class A | Active |
| Total Cholesterol (CHO) Test Kit (CHOD-PAP) | R：120mL×1(703) | EUDAMEDFDA UDI | IVD General | Active |
| Total Protein (TP) Test Kit (Biuret) | R:100mL×2（708） | EUDAMEDFDA UDI | IVD General | Active |
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