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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 1 of 4

Device	Model / Reference	Registries	Class	Status
Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit	RT6005	EUDAMED	Class C	Active
Magicl Ca125 (clia)	CLIA3036A	EUDAMED	Class C	Active
β2-MG Fast Test Kit (Immunofluorescence Assay)	IF5011	EUDAMED	Class B	Active
MAGICL Cortisol (CLIA)	CLIA3016A	EUDAMED	Class B	Active
T3 Fast Test Kit (Immunofluorescence Assay)	IF5022	EUDAMED	Class B	Active
MAGICL Cortisol (CLIA)	CLIA3016A	EUDAMED	Class B	Active
Influenza A/B Rapid Test	CG2059	EUDAMED	Class B	Active
Akso HPV Real-time PCR Kit	RT6003	EUDAMED	Class C	Active
Akso HPV Real-time PCR Kit	RT6003	EUDAMED	Class C	Active
Akso HPV Real-time PCR Kit	RT6003	EUDAMED	Class C	Active
T4 Fast Test Kit (Immunofluorescence Assay)	IF5023	EUDAMED	Class B	Active
Akso HPV Real-time PCR Kit	RT6003	EUDAMED	Class C	Active
SAA Fast Test Kit (Immunofluorescence Assay)	IF5044	EUDAMED	Class B	Active
Magicl Tb-Igra (clia)	CLIA3147A	EUDAMED	Class C	Active
Insulin Fast Test Kit (Immunofluorescence Assay)	IF5146	EUDAMED	Class B	Active
Influenza A/B Rapid Test	CG2059	EUDAMED	Class B	Active
Testosterone Fast Test Kit (Immunofluorescence Assay)	IF5073	EUDAMED	Class B	Active
IL-6 Fast Test Kit (Immunofluorescence Assay)	IF5088	EUDAMED	Class B	Active
TSH Fast Test Kit (Immunofluorescence Assay)	IF5024	EUDAMED	Class B	Active
Magicl Tb-Igra (clia)	CLIA3147A	EUDAMED	Class C	Active
Magicl Il-6 (clia)	CLIA3046A	EUDAMED	Class B	Active
MAGICL Syphilis (CLIA)	CLIA3062A	EUDAMED	Class C	Active
Magicl Il-6 (clia)	CLIA3046A	EUDAMED	Class B	Active
Akso HPV Real-time PCR Kit	RT6003	EUDAMED	Class C	Active
hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay)	IF5003	EUDAMED	Class C	Active
Magicl Ca125 (clia)	CLIA3036A	EUDAMED	Class C	Active
Magicl Il-6 (clia)	CLIA3046A	EUDAMED	Class B	Active
Akso HPV Real-time PCR Kit	RT6003	EUDAMED	Class C	Active
MAGICL Progesterone (CLIA)	CLIA3022A	EUDAMED	Class B	Active
Magicl Ca125 (clia)	CLIA3036A	EUDAMED	Class C	Active
MAGICL Progesterone (CLIA)	CLIA3022A	EUDAMED	Class B	Active
Magicl Tb-Igra (clia)	CLIA3147A	EUDAMED	Class C	Active
PCT Fast Test Kit (Immunofluorescence Assay)	IF5007	EUDAMED	Class C	Active
Magicl Il-6 (clia)	CLIA3046A	EUDAMED	Class B	Active
NGAL Fast Test Kit (Immunofluorescence Assay)	IF5010	EUDAMED	Class B	Active
Magicl Tb-Igra (clia)	CLIA3147A	EUDAMED	Class C	Active
MAGICL Cortisol (CLIA)	CLIA3016A	EUDAMED	Class B	Active
Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay)	IF5001	EUDAMED	Class C	Active
MAGICL Progesterone (CLIA)	CLIA3022A	EUDAMED	Class B	Active
Magicl Il-6 (clia)	CLIA3046A	EUDAMED	Class B	Active
MAGICL Progesterone (CLIA)	CLIA3022A	EUDAMED	Class B	Active
Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit	RT6005	EUDAMED	Class C	Active
CK-MB Fast Test Kit (Immunofluorescence Assay)	IF5018	EUDAMED	Class C	Active
Magicl Il-6 (clia)	CLIA3046A	EUDAMED	Class B	Active
SAA/CRP Fast Test Kit (Immunofluorescence Assay)	IF5090	EUDAMED	Class B	Active
Akso HPV Real-time PCR Kit	RT6003	EUDAMED	Class C	Active
Vitamin B12 Fast Test Kit (Immunofluorescence Assay)	IF5070	EUDAMED	Class B	Active
Akso EV/CA16/EV71 Real-time RT-PCR Kit	RT6002	EUDAMED	Class C	Active
MAGICL Progesterone (CLIA)	CLIA3022A	EUDAMED	Class B	Active
MAGICL Progesterone (CLIA)	CLIA3022A	EUDAMED	Class B	Active

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