Getein Biotech, Inc.
Manufacturer and brand owner in Nanjing, Jiangsu, China. 19 device types, 10 products catalogued.
Getein Biotech, Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Fluorometer, Radioimmunoassay, Estriol and 17 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
19device types registered with the FDA
10products catalogued under its own name
Registration
| Registered name | GETEIN BIOTECH, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009984016 |
| FEI number | 3009984016 |
| DUNS | 542973494 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 基蛋生物科技股份有限公司 |
|---|---|
| Unified social credit code | 913201007360621166 |
| Source | NMPA UDI database |
Location
| City | Nanjing |
|---|---|
| Province | Jiangsu |
| Address | No.9 Bofu Road, Luhe District, |
| Postal code | 211505 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class 1 | MAGICL 6000 Chemiluminescence Immunoassay Analyzer, MAGICL 6800 Chemiluminescence Immunoassay Analyzer, Getein 1100 Immunofluorescence Quantitative Analyzer, MAGICL 6000i Chemiluminescence Immunoassay Analyzer, Getein 208 Hand-held Integrated System, MAGICL 6200 Chemiluminescence Immunoassay Analyzer and 6 more | 2020 | 16 |
| Analyzer, Chemistry, Micro, For Clinical Use | Class 1 | CM-400 Clinical Chemistry Analyzer, CM-800 Clinical Chemistry Analyzer | 2026 | 3 |
| Calibrator, Multi-Analyte Mixture | Class 2 | Lipid Compound Calibrator, Composite Calibrator serum | 2023 | 3 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | Class 2 | T4 Fast Test Kit (Immunofluorescence Assay) | 2026 | 2 |
| Fluorometer | Class 1 | Getein 1150 Immunofluorescence Quantitative Analyzer | 2026 | 8 |
| Multi-Analyte Controls, All Kinds (Assayed) | Class 1 | Thyroid function series Multi Control 1, Hormone series Multi Control 1 | 2026 | 1 |
| Radioimmunoassay, C-Peptides Of Proinsulin | Class 1 | MAGICL C- Peptide (CLIA), C-Peptide Fast Test Kit (Immunofluorescence Assay) | 2026 | 6 |
| Radioimmunoassay, Estradiol | Class 1 | MAGICL Estradiol (CLIA) | 2023 | 5 |
| Radioimmunoassay, Estriol | Class 1 | Magicl UE3 (Clia) | 2023 | 1 |
| Radioimmunoassay, Follicle-Stimulating Hormone | Class 1 | Magicl FSH (Clia) | 2023 | 6 |
| Radioimmunoassay, Human Growth Hormone | Class 1 | MAGICL hGH (CLIA) | 2023 | 5 |
| Radioimmunoassay, Immunoreactive Insulin | Class 1 | Insulin Fast Test Kit(Immunofluorescence Assay), MAGICL Insulin (CLIA) | 2026 | 4 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | Magicl LH (Clia) | 2023 | 16 |
| Radioimmunoassay, Progesterone | Class 1 | MAGICL Progesterone (CLIA) | 2023 | 4 |
| Radioimmunoassay, Prolactin (Lactogen) | Class 1 | Magicl PRL (Clia) | 2023 | 6 |
| Radioimmunoassay, Thyroxine-Binding Globulin | Class 2 | MAGICL Tg (CLIA) | 2023 | 2 |
| Radioimmunoassay, Total Thyroxine | Class 2 | Magicl T4 (Clia) | 2023 | 5 |
| Radioimmunoassay, Total Triiodothyronine | Class 2 | Magicl T3 (Clia), T3 Fast Test Kit (Immunofluorescence Assay), Magicl FT3 (Clia) | 2023 | 5 |
| Real Time Nucleic Acid Amplification System | Class 2 | GN 7120 Akso PCR System, GN 7000 Akso PCR System | 2026 | 15 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| GN 7120 Akso PCR System | OOI | 1 |
| GN 7000 Akso PCR System | OOI | 1 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Employees | 1700+ |
| Main products | Chemiluminescence immunoassay analyzers, Clinical Chemistry analyzers, Hematology analyzers, Coagulation analyzers, Molecular diagnostics systems |
| Certifications | NMPA, CE, IFCC |
| Export markets | 130+ countries and territories |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.