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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 3 of 4
DeviceModel / ReferenceRegistriesClassStatus
Dynamiker FR-CRP Assay(Chemiluminescence) DNK-1901-34
EUDAMED
IVD GeneralActive
Dynamiker Gram Negative Bacterial Endotoxin Assay (Colorimetric) DNK-1410-1
EUDAMED
IVD GeneralActive
Dynamiker SARS-CoV-2 Ag Rapid Test(Nasal Swab) DNK-1425-1N
EUDAMED
IVD GeneralActive
Novel Coronavirus (2019-nCoV) RT-PCR Kit (Saliva) DNK-2106-1
EUDAMED
IVD GeneralActive
Monkeypox Virus Real-time PCR Kit DNK-2115-1
EUDAMED
IVD GeneralActive
Dynamiker Candida albicans IgG Assay (POCT Chemiluminescence) DNK-1901-61
EUDAMED
IVD GeneralActive
QuicGTM Fungus (1-3)-β-D-Glucan Lateral Flow Assay DNK-2301-1
EUDAMED
IVD GeneralActive
Dynamiker Fungal Nucleic Acid Extraction Kit DNK-1901-23
EUDAMED
IVD GeneralActive
Dynamiker Total IgE Assay(Chemiluminescence) DNK-1901-35
EUDAMED
IVD GeneralActive
Dynamiker Mycobacterium tuberculosis IgG Assay (Chemiluminescence) DNK-1901-40
EUDAMED
IVD GeneralActive
Dynamiker Inhibin B(INHB) Assay (Chemiluminescence) DNK-1901-41
EUDAMED
IVD GeneralActive
Dynamiker Cryptococcus neoformans Antigen Assay (POCT Chemiluminescence) DNK-1901-62
EUDAMED
IVD GeneralActive
Dynamiker Candida Mannan Assay(Chemiluminescence) DNK-1901-28
EUDAMED
IVD GeneralActive
Dynamiker Fungus (1-3)-β-D-Glucan Assay(Chromogenic) DNK-1901-1
EUDAMED
IVD GeneralActive
Dynamiker SAA Assay(Chemiluminescence) DNK-1901-32
EUDAMED
IVD GeneralActive
Dynamiker Cryptococcal antigen Assay(Chemiluminescence) DNK-1901-27
EUDAMED
IVD GeneralActive
Dynamiker Monkeypox Virus Ag Rapid Test DNK-2114-1
EUDAMED
IVD GeneralActive
Novel Coronavirus (2019-nCoV) RT PCR Kit DNK-1418-1
EUDAMED
IVD GeneralActive
Fungus (1-3) -β-D Glucan Calibrator DNK-1901-3
EUDAMED
IVD GeneralActive
Dynamiker Fungus (1-3)-β-D-Glucan Assay (Chemiluminescence) DNK-1901-50
EUDAMED
IVD GeneralActive
Dynamiker CRP Assay(Chemiluminescence) DNK-1901-33
EUDAMED
IVD GeneralActive
Dynamiker Aspergillus IgG Assay(Chemiluminescence) DNK-1901-37
EUDAMED
IVD GeneralActive
Fungus (1-3)-β-D Glucan Control DNK-1901-2
EUDAMED
IVD GeneralActive
2019-nCOV IgM Antibody kit (ELISA) DNK-1421-1
EUDAMED
IVD GeneralActive
Dynamiker Cryptococcal Antigen Lateral Flow Assay(LFA) DNK-1411-1
EUDAMED
IVD GeneralActive
Dynamiker Fungus (1-3)-β-D-Glucan Assay(Chromogenic) DNK-1901-1
EUDAMED
IVD GeneralActive
Dynamiker Influenza A+B Ag Rapid Test DNK-2103-1
EUDAMED
IVD GeneralActive
Dynamiker Influenza B IgM Assay (Chemiluminescence) DNK-1901-52
EUDAMED
IVD GeneralActive
Dynamiker SARS-CoV-2 Ag Rapid Test (POCT Chemiluminescence) DNK-1901-57
EUDAMED
IVD GeneralActive
Dynamiker Allergen M3 Aspergillus fumigatus(Chemiluminescence) DNK-1901-36
EUDAMED
IVD GeneralActive
Dynamiker AMH Assay(Chemiluminescence) DNK-1901-39
EUDAMED
IVD GeneralActive
Dynamiker IL-6 Assay(Chemiluminescence) DNK-1901-30
EUDAMED
IVD GeneralActive
2019-nCOV IgM Antibody kit (Chemiluminescence) DNK-1423-1
EUDAMED
IVD GeneralActive
Endotoxin LPS Control DNK-1901-5
EUDAMED
IVD GeneralActive
QuicIgGTM Candida IgG Ab Lateral Flow Assay DNK-2111-1
EUDAMED
IVD GeneralActive
QuicNATM SARS-CoV-2 Neutralization Ab Lateral Flow Assay DNK-1901-10
EUDAMED
IVD GeneralActive
Dynamiker Mycobacterium tuberculosis IgG Assay (Chemiluminescence) DNK-1901-40
EUDAMED
IVD GeneralActive
QuicIgETM Total IgE Lateral Flow Assay DNK-1901-15
EUDAMED
IVD GeneralActive
Dynamiker PCT Assay(Chemiluminescence) DNK-1901-31
EUDAMED
IVD GeneralActive
Dynamiker Influenza B IgM Assay (Chemiluminescence) DNK-1901-52
EUDAMED
IVD GeneralActive
Dynamiker Aspergillus IgE Ab Assay (POCT Chemiluminescence) DNK-1901-53
EUDAMED
IVD GeneralActive
Dynamiker Aspergillus fumigatus IgG Assay (POCT Chemiluminescence) DNK-1901-60
EUDAMED
IVD GeneralActive
Dynamiker Gram Negative Bacterial Endotoxin Assay(Chromogenic) DNK-1901-4
EUDAMED
IVD GeneralActive
Dynamiker Candida IgG Lateral Flow Assay( LFA) DNK-1413-1
EUDAMED
IVD GeneralActive
Dynamiker Legionella pneumophila IgM Assay (Chemiluminescence) DNK-1901-44
EUDAMED
IVD GeneralActive
Fungus (1-3) -β-D Glucan Calibrator DNK-1901-3
EUDAMED
IVD GeneralActive
MycoMDx Mucor PCR Assay DNK-2108-1
EUDAMED
IVD GeneralActive
Dynamiker Candida Mannan Assay (POCT Chemiluminescence) DNK-1901-59
EUDAMED
IVD GeneralActive
MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR) DNK-1901-21
EUDAMED
IVD GeneralActive
Endotoxin LPS Control DNK-1901-5
EUDAMED
IVD GeneralActive

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