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Getein 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Wei Chen
EUDAMED SRN: CN-MF-000017986
FDA FEI Number: 3009984016
DUNS Number: —

Catalogue (189)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
MAGICL free β-HCG (CLIA)	/	EUDAMED	IVD General	Active
TnT Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Anti-Tg Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Iaa (clia)	/	EUDAMED	IVD General	Active
CA15-3 Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Dd (clia)	/	EUDAMED	IVD General	Active
Magicl Tsh (clia)	、	EUDAMED	IVD General	Active
25-OH-VD Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
RSV Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
fT4 Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
CA19-9 Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
RF Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
CEA Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Anti-CCP Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Ferritin Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
MAGICL Estradiol (CLIA)	/	EUDAMED	IVD General	Active
CysC Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Hbp (clia)	/	EUDAMED	IVD General	Active
H. pylori Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Ue3 (clia)	/	EUDAMED	IVD General	Active
ST2 Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Prog Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Saa (clia)	/	EUDAMED	IVD General	Active
Magicl Shbg (clia)	/	EUDAMED	IVD General	Active
D-Dimer Fast Test Kit (Immunofluorescence Assay )	/	EUDAMED	IVD General	Active
ASO Fast Test Kit (Immunofluorescence Assay)	IF1076	EUDAMED	Class B	Active
hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay )	/	EUDAMED	IVD General	Active
MAGICL Vitamin B12 (CLIA)	/	EUDAMED	IVD General	Active
Magicl S100 (clia)	/	EUDAMED	IVD General	Active
MAGICL HSV-I IgM (CLIA)	/	EUDAMED	IVD General	Active
Magicl Piiip N-P (clia)	/	EUDAMED	IVD General	Active
Magicl Tm (clia)	/	EUDAMED	IVD General	Active
MAGICL Tg (CLIA)	/	EUDAMED	IVD General	Active
Getein	/	EUDAMED	IVD General	Active
Anti-TP Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Il-10 (clia)	/	EUDAMED	IVD General	Active
HCG+β Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Scc (clia)	/	EUDAMED	IVD General	Active
Magicl Papp-A (clia)	/	EUDAMED	IVD General	Active
Getein 1160 Immunofluorescence Quantitative Analyzer	GP1004	EUDAMED	IVD General	Active
AMH Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl T4 (clia)	/	EUDAMED	IVD General	Active
Magicl Pic (clia)	/	EUDAMED	IVD General	Active
MAGICL hs-cTnI (CLIA)	/	EUDAMED	IVD General	Active
MAGICL ProGRP (CLIA)	/	EUDAMED	IVD General	Active
Magicl Pgi (clia)	/	EUDAMED	IVD General	Active
PCT/CRP Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Getein	/	EUDAMED	IVD General	Active
Magicl Pct (clia)	/	EUDAMED	IVD General	Active
Anti-TPO Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active

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