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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 panels for infections - various
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Respiratory tract infections - multiplex na reagents
Respiratory tract infections - multiplex na reagents
W0105070503
271 devices
Allplex™ Respiratory Panel 1A
Seegene Inc.
·
,
South Korea
IVD General
CE/IVDD
RIDA®Plex Respiratory Pathogens 12 well Step 2
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
ChainFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
RespiBio® Panel 1
Serosep Limited
·
,
Ireland
IVD General
CE/IVDD
Multiple-type Respiratory Pathogen Nucleic Acid Kit (Fluorescent PCR)
Henan Vacure Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(…
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
RevoDx Respiratory-5 Pathogen Detection Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
Triplex Real-Time PCR Kit for Detection of Escherichia coli/Enterobacter cloaca…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
RIDA®GENE CAP Bac
R-Biopharm AG
·
,
Germany
Class C
CE/IVDR
Tigsun MP/CP/RSV/AdV/Cox B Combo IgM Rapid Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Influenza A/B Virus, SARS-CoV-2 and Respiratory Syncytial Virus Nucleic Acid De…
Guangzhou Deaou Gene Technology Co., Ltd
·
,
China
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
Tigsun MP/CP/RSV/AdV/Cox B Combo IgM Rapid Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
ZENA MAX Respiratory Panel 3 SARS-CoV-2, Influenza A&B and H1N1 Real Time PCR D…
Advanced Molecular Diagnostics Ltd
·
,
United Kingdom
IVD General
CE/IVDD
Respiratory Pathogens Detection Kit
Guangzhou KingCreate Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Panther Fusion AdV/hMPV/RV Assay
Hologic
·
,
United States
Class B
FDA 510(k)
×2
K231017
Active
Cleared 5 May 2023
CE/IVDR
+1
authorizations
RIDA®Plex Respiratory Pathogens 16 well Step 1
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
RIDA®Plex Respiratory Pathogens C 16 well Step 2
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
RevoDx Moraxella catarrhalis/ Haemophilus influenzae/ Streptococcus pyogenes qP…
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
Duplex Real-Time PCR Detection Kit for Mycoplasma pneumoniae and Legionella pne…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
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