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In vitro diagnostic medical devices
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Infectious diseases
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Multiple parameters - (infect. immunology/nat)
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Multiple panels for infections - various
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Respiratory tract infections - multiplex na reagents
Respiratory tract infections - multiplex na reagents
W0105070503
271 devices
Triplex Real-time PCR Detection Kit for Middle East Respiratory Syndrome (MERS)
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
Allplex™ Respiratory Panel 1A
Seegene Inc.
·
,
South Korea
IVD General
CE/IVDD
RIDA®Plex Atypical Pneumonia 8 well Step 1
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
RevoDx Respiratory-24 v2.0 Pathogen Detection Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
Tigsun MP/CP/RSV/AdV/Cox B Combo IgM Rapid Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
RevoDx Respiratory-24 v2.0 Pathogen Detection Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
Allplex™ Respiratory Panel 2
Seegene Inc.
·
,
South Korea
IVD General
CE/IVDD
Duplex Real-Time PCR Detection Kit for Mycoplasma Pneumoniae and Bordetella Per…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
Influenza & SARS-CoV-2 Antigen Combo Test Kit（Colloidal Gold Immunochromatograp…
Shenzhen Reetoo Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
PilotTM Multiple Respiratory Pathogens Digital PCR Kit
Pilot Gene Technology (Hangzhou) Co., Ltd
·
,
China
IVD General
CE/IVDD
Allplex™ Respiratory Panel 2
Seegene Inc.
·
,
South Korea
IVD General
CE/IVDD
RIDA®Plex Pneumonia 16 well Step 1
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Allplex™ RV Master Assay
Seegene Inc.
·
,
South Korea
Class B
CE/IVDD
CE/IVDR
Tigsun MP/CP/RSV/AdV/Cox B Combo IgM Rapid Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Upper Respiratory Pathogens 16-well
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
Allplex™ Respiratory Panel 4
Seegene Inc.
·
,
South Korea
IVD Annex II List B
CE/IVDD
Respiratory Pathogens 12-well
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
LyoSens™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDR
CE/IVDD
Human Parainfluenza Virus and Adenovirus Nucleic Acid Detection Kit (Real-time …
Guangzhou Deaou Gene Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Sansure Biotech Inc.
·
,
China
Class C
CE/IVDR
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