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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
Respiratory 15 Types Virus Nucleic Acid Multiplex Detection Kit (Fluorescence P…
Suzhou TianLong Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Allplex™ PneumoBacter Assay
Seegene Inc.
·
,
South Korea
IVD Annex II List B
CE/IVDR
CE/IVDD
Anatolia Geneworks
Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
·
,
Türkiye
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
RIDA®Plex Respiratory Pathogens 24 well Step 2
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay
Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
·
,
Taiwan
IVD General
CE/IVDD
Allplex™ PneumoBacter Assay
Seegene Inc.
·
,
South Korea
IVD Annex II List B
CE/IVDD
GeneMind
GeneMind Biosciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
Allplex™ Respiratory Panel 2
Seegene Inc.
·
,
South Korea
IVD General
CE/IVDD
Comprehensive Respiratory Virus Panel
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
RIDA®Plex Respiratory Pathogens C 16 well Step 1
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2, Respiratory Syncytium, and Influenza A&B Antigen Combined Detection…
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Step 1 tubes for Pneumonia (16-well)
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Step 1 tubes for Atypical Pneumonia (8-well)
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
RevoDx Respiratory-6 Pathogen Detection Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
RevoDx Respiratory-6 Pathogen Detection Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
RIDA®Plex Respiratory Viruses 16 well Step 2
AusDiagnostics Pty Ltd
·
,
Australia
IVD General
CE/IVDD
RevoDx Respiratory-5 version 4.0 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
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