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Daan Gene Co., Ltd.

China·CN-MF-000025799

Last updated June 8, 2026

Information

Country
China
Address
No. 19, Xiangshan Road, Science Park, High & New Technology Development District, Guangzhou, China
Website
daangene.com
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Jie Huang
EUDAMED SRN
CN-MF-000025799
FDA FEI Number
—
DUNS Number
—

Catalogue (127)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Diagnostic Kit for Quantification of Neisseria Gonorrhoeae (PCR-Fluorescence Probing) DA0060
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction Kit DA0602-2
EUDAMED
Class AActive
RNA/DNA Purification Kit (Spin Column) DA0590
EUDAMED
Class AActive
RNA/DNA Extraction or Purification Kit DA1272
EUDAMED
Class AActive
Specimen Preservation Solution DA0983
EUDAMED
Class AActive
Diagnostic Kit for Dengue Virus RNA (PCR-Fluorescence Probing) DA0310
EUDAMED
IVD GeneralActive
Detection Kit for Severe Fever with Thrombocytopenia Syndrome Bunyavirus (PCR-Fluorescence Probing) DA0340
EUDAMED
IVD GeneralActive
Detection Kit for 2019-nCoV Nucleic Acid (Thermostatic Amplification-LFIA) DA1391
EUDAMED
IVD GeneralActive
Nucleic Acid Isolation or Purification Kit DA0871
EUDAMED
Class AActive
Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) DA0930
EUDAMED
IVD GeneralActive
Nucleic Acid Isolation or Purification Reagent DA0622
EUDAMED
Class AActive
Diagnostic Kit for Dengue Virus RNA (PCR-Fluorescence Probing) DA0312
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction Instrument DA8030
EUDAMED
Class AActive
Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit DA0151
EUDAMED
IVD GeneralActive
RNA/DNA Extraction or Purification Kit DA1270
EUDAMED
Class AActive
Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing) DA0202
EUDAMED
IVD GeneralActive
2019-nCoV Omicron Variant Detection Kit (PCR-Fluorescence) DA1220
EUDAMED
IVD GeneralActive
HPV (16/18 genotypes) DNA TEST (Real-Time PCR) DA0540
EUDAMED
IVD GeneralActive
Sample Processing System DA8050
EUDAMED
Class AActive
Nucleic Acid Extraction Instrument DA8300
EUDAMED
Class AActive
CYP2C19 Genotyping Detection Kit (PCR-Fluorescence Probing) DA0891
EUDAMED
IVD GeneralActive
Nucleic Acid Isolation or Purification Reagent DA0626
EUDAMED
Class AActive
Detection Kit for Enterovirus 71/Coxsackievirus A16/Enterovirus RNA (PCR-Fluorescence Probing) DA0320
EUDAMED
IVD GeneralActive
RNA/DNA Purification Kit (Magnetic Bead) DA0630
EUDAMED
Class AActive
Human Papilloma Virus (HPV) Detection Kit (PCR-Fluorescence Probing) DA1180
EUDAMED
IVD GeneralActive
Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence) DA0051
EUDAMED
IVD GeneralActive
RNA/DNA Purification Kit (Preservation) DA0941
EUDAMED
Class AActive
Nucleic Acid Isolation or Purification Reagent DA0625
EUDAMED
Class AActive
Fluorimetric Immunoassay Analyser DA8210
EUDAMED
Class AActive
2019-nCoV Delta Variant Detection Kit (PCR-Fluorescence Probing) DA1160
EUDAMED
IVD GeneralActive
CYP2C19 Genotyping Detection Kit (PCR-Fluorescence Probing) DA0890
EUDAMED
IVD GeneralActive
Diagnostic Kit for Ureaplasma Urealyticum DNA (PCR-Fluorescence Probing) DA0080
EUDAMED
IVD GeneralActive
Nucleic Acid Isolation or Purification Reagent DA0624
EUDAMED
Class AActive
Nucleic Acid Extraction Kit DA0601-1
EUDAMED
Class AActive
Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing) DA0200
EUDAMED
IVD GeneralActive
Detection Kit for Influenza A/B and 2019-nCoV (PCR-Fluorescence Probing) DA1040
EUDAMED
IVD GeneralActive
Real-time PCR Detection System DA8120
EUDAMED
Class AActive
Detection Kit for 2019-nCoV (PCR-Fluorescence) DA0994
EUDAMED
IVD GeneralActive
Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit DA0150
EUDAMED
IVD GeneralActive
HPV (6/11 genotypes) DNA TEST (Real-Time PCR) DA0530
EUDAMED
IVD GeneralActive
Diagnostic Kit for Human Influenza Virus B RNA (PCR-Fluorescence Probing) DA0240
EUDAMED
IVD GeneralActive
RNA/DNA Purification Kit (Spin Column) DA0591
EUDAMED
Class AActive
Detection Kit for SARS-CoV-2 UK and South African Variants (PCR-Fluorescence) DA1061
EUDAMED
IVD GeneralActive
Specimen Preservation Solution DA0981
EUDAMED
Class AActive
Specimen Preservation Solution DA0986
EUDAMED
Class AActive
2019-nCoV Delta Variant Detection Kit (PCR-Fluorescence Probing) DA1161
EUDAMED
IVD GeneralActive
Detection Kit for 2019-nCoV (PCR-Fluorescence) DA0990
EUDAMED
IVD GeneralActive
Detection Kit for 2019-nCoV (PCR-Fluorescence) DA0997
EUDAMED
IVD GeneralActive
Detection Kit for Enterovirus 71/Coxsackievirus A16/Enterovirus RNA (PCR-Fluorescence Probing) DA0322
EUDAMED
IVD GeneralActive
Detection Kit for Norovirus RNA (PCR-Fluorescence Probing) DA1152
EUDAMED
IVD GeneralActive

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