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Sign in to claim this brandGetein Biotech, Inc.
China·CN-MF-000017986
Last updated September 17, 2026
What Getein Biotech, Inc. makes
Getein Biotech, Inc. manufactures in vitro diagnostic (IVD) tests for infectious disease detection and hormone/protein biomarker analysis. Their product line includes real-time RT-PCR kits for SARS-CoV-2, influenza A/B, and human papillomavirus (HPV), as well as rapid immunoassay tests for cortisol, thyroid hormones (T3/T4), β2-microglobulin, and cancer biomarkers like CA125. The company also produces chemiluminescent immunoassay (CLIA) devices for cortisol and CA125 measurements.
The company’s IVD devices are classified under EU regulations as Class A, B, C, and IVD General, with several products registered in the EU’s eudamed database. While primarily focused on Chinese markets, their diagnostics are also authorised for use in jurisdictions adhering to EU IVD directives. The portfolio spans both low-risk rapid tests and higher-complexity molecular and immunoassay systems.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- China
- Address
- No.9 Bofu Road, Luhe District, Nanjing, Jiangsu 211505, China, Nanjing, China
- Website
- getein.com.cn
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Wei Chen
- EUDAMED SRN
- CN-MF-000017986
- FDA FEI Number
- 3009984016
- DUNS Number
- —
Catalogue (189)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Magicl Ha (clia) | CLIA3070A | EUDAMED | Class B | Active |
| MAGICL Progesterone (CLIA) | CLIA3022A | EUDAMED | Class B | Active |
| Magicl Prl (clia) | / | EUDAMED | IVD General | Active |
| Magicl Nse (clia) | / | EUDAMED | IVD General | Active |
| Magicl H-Fabp (clia) | / | EUDAMED | IVD General | Active |
| MAGICL hs-cTnT (CLIA) | / | EUDAMED | IVD General | Active |
| Magicl Cyfra21-1 (clia) | / | EUDAMED | IVD General | Active |
| HbA1c Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| Getein | / | EUDAMED | IVD General | Active |
| CK-MB Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| MAGICL Lp-PLA2 (CLIA) | / | EUDAMED | IVD General | Active |
| MAGICL HSV-II IgG (CLIA) | / | EUDAMED | IVD General | Active |
| Getein | / | EUDAMED | IVD General | Active |
| Osteocalcin Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| Magicl Pivka-Ii (clia) | / | EUDAMED | IVD General | Active |
| MAGICL Testosterone (CLIA) | / | EUDAMED | IVD General | Active |
| BNP Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| LH Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| IL-6 Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| Getein | / | EUDAMED | IVD General | Active |
| Estradiol Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| Magicl Lh (clia) | / | EUDAMED | IVD General | Active |
| Magicl St2 (clia) | / | EUDAMED | IVD General | Active |
| UA Reagent Kit-2 (Uricase Method) | CC1080 | EUDAMED | Class B | Active |
| MAGICL Syphilis (CLIA) | / | EUDAMED | IVD General | Active |
| MAGICL HbA1c (CLIA) | / | EUDAMED | IVD General | Active |
| CK-MB/cTnI Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| Magicl Fsh (clia) | / | EUDAMED | IVD General | Active |
| Getein | / | EUDAMED | IVD General | Active |
| Magicl G17 (clia) | / | EUDAMED | IVD General | Active |
| PGⅠ/PGⅡ Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| Magicl Ha (clia) | / | EUDAMED | IVD General | Active |
| Magicl Il-2r (clia) | / | EUDAMED | IVD General | Active |
| NT-proBNP Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| MAGICL Ferritin (CLIA) | / | EUDAMED | IVD General | Active |
| MAGICL Renin (CLIA) | / | EUDAMED | IVD General | Active |
| Magicl Β2-Mg (clia) | / | EUDAMED | IVD General | Active |
| MAGICL Progesterone (CLIA) | / | EUDAMED | IVD General | Active |
| Magicl Tnf-Α (clia) | / | EUDAMED | IVD General | Active |
| MAGICL HSV-II IgM (CLIA) | / | EUDAMED | IVD General | Active |
| Total IgE Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| Magicl Dhea-S (clia) | / | EUDAMED | IVD General | Active |
| Calprotectin Fast Test Kit (Immunofluorescence Assay) | / | EUDAMED | IVD General | Active |
| Getein | / | EUDAMED | IVD General | Active |
| MAGICL Osteocalcin (CLIA) | / | EUDAMED | IVD General | Active |
| Magicl Igfbp-3 (clia) | / | EUDAMED | IVD General | Active |
| Magicl Ngal (clia) | / | EUDAMED | IVD General | Active |
| Getein1200 Immunofluorescence Quantitative Analyzer | Getein1200 | EUDAMED | Class A | Active |
| MAGICL Myo (CLIA) | / | EUDAMED | IVD General | Active |
| MAGICL hGH (CLIA) | / | EUDAMED | IVD General | Active |
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