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Sign in to claim this brandMedicalsystem Biotechnology Co., Ltd.
US
Last updated May 30, 2026
What Medicalsystem Biotechnology Co., Ltd. makes
Medicalsystem Biotechnology Co., Ltd. manufactures in vitro diagnostic (IVD) kits for laboratory testing, including total protein, beta-2-microglobulin, haptoglobin, albumin, total aspartate aminotransferase (AST), total lactate dehydrogenase (LDH), and LDH-4 isoenzyme assays. Their products use methods such as enzyme spectrophotometry, nephelometry/turbidimetry, and immunoturbidimetry for quantitative analysis in clinical settings.
The company’s IVD kits are classified as Class II devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory standards for diagnostic testing.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 545261989
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Total Protein Kit (Biuret Method) | None | FDA UDI | Class II | Active |
| Lactate Dehydrogenase Kit (Kinetic Method) | None | FDA UDI | Class II | Active |
| Aspartate Aminotransferase Kit (Colorimetric Method ) | None | FDA UDI | Class II | Active |
| Total Protein Kit (Biuret Method) (2-Part Reagents) | None | FDA UDI | Class II | Active |
| Microalbuminuria Kit (Immunoturbidimetric Method) | None | FDA UDI | Class II | Active |
| Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method) | None | FDA UDI | Class II | Active |
| Haptoglobin Kit (Immunoturbidimetric Method) | None | FDA UDI | Class II | Active |
| β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method) | None | FDA UDI | Class II | Active |
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