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Dynamiker Biotechnology (Tianjin) Co., Ltd.

China·CN-MF-000001133

Last updated September 17, 2026

What Dynamiker Biotechnology (Tianjin) Co., Ltd. makes

Dynamiker Biotechnology (Tianjin) Co., Ltd. manufactures nucleic acid extraction/isolation kits and allergen-specific immunoglobulin E (IgE) antibody reagents for in vitro diagnostic use. Their product portfolio includes PCR assays for detecting various fungal pathogens such as Mucor, Candida, Talaromyces marneffei, Aspergillus, and Pneumocystis jirovecii, as well as tests for carbapenem resistance genes, respiratory viruses including Flu A/B, HRV, HMPV, ADV, and MP, and a lateral flow assay for antigens.

The company's devices are classified as IVD General and are listed in the eudamed regulatory registry. Dynamiker Biotechnology is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Dynamiker Biotechnology (Tianjin) Co., Ltd. manufacture?

Dynamiker Biotechnology manufactures nucleic acid extraction/isolation kits and allergen-specific immunoglobulin E (IgE) antibody reagents for in vitro diagnostic use. Their products include PCR assays for detecting various fungal pathogens, tests for carbapenem resistance genes, respiratory virus tests, and lateral flow assay antigen tests.

Where is Dynamiker Biotechnology (Tianjin) Co., Ltd. based?

Dynamiker Biotechnology (Tianjin) Co., Ltd. is based in China. The company's location is indicated by the country code 'CN' in their regulatory information.

Which regulatory registries list Dynamiker Biotechnology's devices?

Dynamiker Biotechnology's devices are listed in the eudamed regulatory registry. This is the European Union's medical device database where information about medical devices placed on the EU market is recorded.

How are Dynamiker Biotechnology's devices classified?

Dynamiker Biotechnology's devices are classified as IVD General. This classification indicates they are in vitro diagnostic devices intended for general use in medical laboratories for detecting various pathogens and allergens.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
China
Address
No.2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue, Sino-Singapore Eco-city, TEDA, Tianjin, China
LinkedIn
—
Facebook
—
Phone
+86 22 2526 4212
PRRC Contact
Zeqi Zhou
EUDAMED SRN
CN-MF-000001133
FDA FEI Number
3012452932
DUNS Number
—

Catalogue (152)

Page 2 of 4
DeviceModel / ReferenceRegistriesClassStatus
QuicGTM Fungus (1-3)-β-D-Glucan Lateral Flow Assay DNK-2301-1
EUDAMED
IVD GeneralActive
Dynamiker Total IgE Ab Assay (POCT Chemiluminescence) DNK-1901-54
EUDAMED
IVD GeneralActive
Helicobacter pylori IgG antibody test kit (LFA) DNK-2502-1
EUDAMED
IVD GeneralActive
MycoMDx Talaromyces marneffei PCR Assay DNK-2110-1
EUDAMED
IVD GeneralActive
Dynamiker Antimuller canal hormone(AMH) Assay (ELISA) DNK-1901-25
EUDAMED
IVD GeneralActive
Dynamiker SARS-CoV-2 Neutralization Antibody ELISA Assay DNK-2102-1
EUDAMED
IVD GeneralActive
MycoMDx Candida auris PCR Kit DNK-2510-1
EUDAMED
IVD GeneralActive
Dynamiker Fungus (1-3)-β-D-Glucan Assay DNK-1401-1
EUDAMED
IVD GeneralActive
Automatic immunobiochemical analyzer WD240
EUDAMED
IVD GeneralActive
Dynamiker Nucleic Acid Extraction Kit DNK-1901-22
EUDAMED
IVD GeneralActive
MyCOMDx PCR Assay for Detection of 3 Fungal Pathogens DNK-2401-1
EUDAMED
IVD GeneralActive
2019-nCOV IgG Antibody kit (Chemiluminescence) DNK-1422-1
EUDAMED
IVD GeneralActive
Candida/Trichomonas vaginalis/Gardnerella vaginalis Antigen Combo Test Kit (Latex Chromatography Method) DNK-2508-1
EUDAMED
IVD GeneralActive
Dynamiker Influenza A Antigen Assay (Chemiluminescence) DNK-1901-42
EUDAMED
IVD GeneralActive
QuicGXMTM Cryptococcus neoformans Ag Lateral Flow Assay DNK-2113-1
EUDAMED
IVD GeneralActive
QuicIgGTM Aspergillus IgG Ab Lateral Flow Assay DNK-1415-1
EUDAMED
IVD GeneralActive
MycoMDx Carbapenem resistance gene Assay (F-PCR) DNK-1901-20
EUDAMED
IVD GeneralActive
QuicMnTM Candida Mannan Ag Lateral Flow Assay DNK-2112-1
EUDAMED
IVD GeneralActive
MycoMDx Aspergillus PCR Assay DNK-1416-1
EUDAMED
IVD GeneralActive
2019-nCoV IgG/IgM Rapid Test DNK-1419-1
EUDAMED
IVD GeneralActive
Dynamiker Fungus (1-3)-β-D-Glucan Assay (POCT Chemiluminescence) DNK-1901-63
EUDAMED
IVD GeneralActive
Fungus (1-3)-β-D Glucan Control DNK-1901-2
EUDAMED
IVD GeneralActive
Endotoxin LPS Calibrator DNK-1901-6
EUDAMED
IVD GeneralActive
Human Rhinovirus antigen test kit (LFA) DNK-2504-1
EUDAMED
IVD GeneralActive
Dynamiker Aspergillus IgG Assay(Chemiluminescence) DNK-1901-37
EUDAMED
IVD GeneralActive
Dynamiker Allergen M3 Aspergillus fumigatus(Chemiluminescence) DNK-1901-36
EUDAMED
IVD GeneralActive
Dynamiker Fungus (1-3)-β-D-Glucan Assay (POCT Chemiluminescence) DNK-1901-63
EUDAMED
IVD GeneralActive
Dynamiker COVID-19/Influenza A+B /RSV Ag Combo Rapid Test DNK-2117-1
EUDAMED
IVD GeneralActive
Dynamiker Mycoplasma pneumoniae IgM Assay (Chemiluminescence) DNK-1901-45
EUDAMED
IVD GeneralActive
Dynamiker Influenza A IgM Assay (Chemiluminescence) DNK-1901-51
EUDAMED
IVD GeneralActive
MycoMDx Candida auris PCR Assay DNK-2107-1
EUDAMED
IVD GeneralActive
Dynamiker Candida IgG Assay(Chemiluminescence) DNK-1901-38
EUDAMED
IVD GeneralActive
Dynamiker Aspergillus Galactomannan Assay(Chemiluminescence) DNK-1901-26
EUDAMED
IVD GeneralActive
Dynamiker CRP Assay(Chemiluminescence) DNK-1901-33
EUDAMED
IVD GeneralActive
2019-nCOV IgM Antibody kit (ELISA) DNK-1421-1
EUDAMED
IVD GeneralActive
Dynamiker Candida IgG Assay(Chemiluminescence) DNK-1901-38
EUDAMED
IVD GeneralActive
2019-nCOV IgG Antibody kit (ELISA) DNK-1420-1
EUDAMED
IVD GeneralActive
Dynamiker COVID-19/Influenza A+B Ag Combo Rapid Test DNK-2104-1
EUDAMED
IVD GeneralActive
QuicAbTM Talaromyces marneffei Ab Lateral Flow Assay DNK-1901-17
EUDAMED
IVD GeneralActive
Dynamiker Total IgE Assay(Chemiluminescence) DNK-1901-35
EUDAMED
IVD GeneralActive
QuicIgETM Aspergillus IgE Ab Lateral Flow Assay DNK-1901-14
EUDAMED
IVD GeneralActive
MycoMDx Pneumocystis jirovecii (PJP) PCR Assay DNK-2109-1
EUDAMED
IVD GeneralActive
Human Metapneumovirus antigen test kit (LFA) DNK-2505-1
EUDAMED
IVD GeneralActive
Dynamiker Influenza B Antigen Assay (Chemiluminescence) DNK-1901-43
EUDAMED
IVD GeneralActive
MycoMDx Pneumocystis jirovecii (PJP) PCR Assay DNK-2109-1
EUDAMED
IVD GeneralActive
Dynamiker Aspergillus Galactomannan Assay DNK-1402-1
EUDAMED
IVD GeneralActive
Dynamiker SARS-CoV-2 Neutralization Antibody Assay (Chemiluminescence) DNK-1901-49
EUDAMED
IVD GeneralActive
Dynamiker Influenza A Antigen Assay (POCT Chemiluminescence) DNK-1901-55
EUDAMED
IVD GeneralActive
Dynamiker Mycoplasma pneumoniae IgG Assay (Chemiluminescence) DNK-1901-46
EUDAMED
IVD GeneralActive
Endotoxin LPS Calibrator DNK-1901-6
EUDAMED
IVD GeneralActive

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