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In vitro diagnostic medical devices
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Reagents
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Infectious diseases
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Multiple parameters - (infect. immunology/nat)
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Multiple viruses panels
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Multiple viruses - multiplex assays - other
Multiple viruses - multiplex assays - other
W0105070399
105 devices
Devices
Flu A/RSV Ag Combo Rapid Test Cassette (Swab)
Healgen Scientific Limited Liability Company
·
,
US
IVD General
CE/IVDD
RIDA®Plex Viral and Syphilis 12 well Step 2
AusDiagnostics Pty Ltd
·
,
AU
IVD Annex II List B
CE/IVDD
SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)
Ningbo BESTest Bio-technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Influenza A/B Antigen Determination Kit (Fluorescence Immunochromatographic Ass…
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
CN
Class B
CE/IVDR
Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus…
Beijing Applied Biological Technologies Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Step 2 Plates for Herpes, Enterovirus and Adenovirus 8-well
AusDiagnostics Pty Ltd
·
,
AU
IVD Annex II List B
CE/IVDD
Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Flu AB + SARS-CoV-2 Antigen Rapid Detection Kit(Colloidal Gold)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
CN
IVD General
CE/IVDD
Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Coxsackie virus group A type 16 & enterovirus type 71 Diagnostic Kit (PCR-Fluor…
Shenzhen Zijian Biotechnology Co., Ltd
·
,
CN
IVD General
CE/IVDD
RevoDx HBV/HCV Qualitative qPCR Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
TR
IVD General
CE/IVDD
RIDA®Plex Viral and Syphilis 12 well Step 1
AusDiagnostics Pty Ltd
·
,
AU
IVD Annex II List B
CE/IVDD
RevoDx HBV/HCV Qualitative qPCR Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
TR
IVD General
CE/IVDD
Five Respiratory Pathogens Nucleic Acid Test Kit(PCR-Fluorescent Probe Method)
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/IVDD
COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)
Anhui Deepblue Medical Technology Co., Ltd
·
,
CN
Class C
CE/IVDR
EU-TDA-FI-20642-800030-2025-1
Active
Valid to Mar 2030
Tigsun Flu A/B, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
CN
IVD General
CE/IVDD
RevoDx HBV/HCV Qualitative qPCR Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
TR
IVD General
CE/IVDD
SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay)
Sansure Biotech Inc.
·
,
CN
IVD General
CE/IVDD
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromat…
Shenzhen Microprofit Biotech Co., Ltd
·
,
CN
IVD for self-testing
CE/IVDD
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