Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
Reagents
/
Infectious diseases
/
Multiple parameters - (infect. immunology/nat)
/
Multiple viruses panels
/
Multiple viruses - multiplex assays - other
Multiple viruses - multiplex assays - other
W0105070399
105 devices
Influenza A&B Ag Test Kit (Time-Resolved FIA)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)
Ningbo BESTest Bio-technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
Tigsun Flu A/B, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluore…
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)
Anhui Deepblue Medical Technology Co., Ltd
·
,
China
Class C
CE/IVDR
EU-TDA-FI-20642-800030-2025-1
Active
Valid to Mar 2030
RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Step 2 Plates for Viral Panel 12-well
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
RIDA®Plex Viral 12 well Step 2
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Viral 8-well
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Viral and Syphilis 12-well
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Dengue Virus, Zika Virus and Chikungunya Virus Multiplex Nucleic Acid Detection…
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Previous
Next