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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 4 of 4

Device	Model / Reference	Registries	Class	Status
Magicl Ln (clia)	/	EUDAMED	IVD General	Active
Magicl Il-8 (clia)	/	EUDAMED	IVD General	Active
FSH Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
fT3 Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl He4 (clia)	/	EUDAMED	IVD General	Active
NGAL Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Il-6 (clia)	/	EUDAMED	IVD General	Active
Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Β-Hcg (clia)	/	EUDAMED	IVD General	Active
Magicl Ft3 (clia)	/	EUDAMED	IVD General	Active
MAGICL rT3 (CLIA)	/	EUDAMED	IVD General	Active
Magicl Pth (clia)	/	EUDAMED	IVD General	Active
Magicl Il-1β (clia)	/	EUDAMED	IVD General	Active
UA Reagent Kit-2 (Uricase Method)	CC1081	EUDAMED	Class B	Active
Getein	/	EUDAMED	IVD General	Active
Magicl Ft4 (clia)	/	EUDAMED	IVD General	Active
MAGICL IgE (CLIA)	/	EUDAMED	IVD General	Active
MAGICL HSV-I IgG (CLIA)	/	EUDAMED	IVD General	Active
AFP Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
MAGICL Folate (CLIA)	/	EUDAMED	IVD General	Active
MAGICL t-PAIC (CLIA)	、	EUDAMED	IVD General	Active
Magicl Tat (clia)	/	EUDAMED	IVD General	Active
MAGICL TMAb (CLIA)	/	EUDAMED	IVD General	Active
Magicl T3 (clia)	/	EUDAMED	IVD General	Active
hs-cTnI Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Crp (clia)	/	EUDAMED	IVD General	Active
Cortisol Fast Test Kit (Immunofluorescence Assay）	/	EUDAMED	IVD General	Active
mAlb Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Magicl Pgⅱ (clia)	/	EUDAMED	IVD General	Active
Getein	/	EUDAMED	IVD General	Active
PCT Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
MAGICL Insulin (CLIA)	/	EUDAMED	IVD General	Active
MAGICL NT-proBNP (CLIA)	/	EUDAMED	IVD General	Active
PRL Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
CA125 Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
Getein	/	EUDAMED	IVD General	Active
Folate Fast Test Kit (Immunofluorescence Assay)	/	EUDAMED	IVD General	Active
H. pylori Antigen Fast Test Kit (Immunofluorescence Assay)	IF1047	EUDAMED	Class B	Active

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