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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 viruses panels
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Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
W0105070304
105 devices
N2 Gene of Influenza Virus A Real Time RT-PCR Kit
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Influenza A/B Virus and Respiratory Syncytial Virus Multiplex Nucleic Acid Diag…
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
geneMAP
Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit
KogeneBiotech Co., Ltd.
·
,
South Korea
IVD General
CE/IVDD
cobas® eplex respiratory pathogen panel 3 (RP3)
GenMark Diagnostics
·
,
United States
Class B
FDA 510(k)
K163636
Active
Cleared 9 Jun 2017
CE/IVDR
Influenza Virus C Real Time RT-PCR Kit
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
StrongStep® Influenza A/B & RSV Multiplex Real-Time PCR Kit
Nanjing Liming Bio-products Co. Ltd
·
,
China
IVD General
CE/IVDD
TRUPCR® Flu Panel with RSV detection Kit
3B BlackBio Dx Limited
·
,
India
Class B
CE/IVDR
Influenza A/Influenza B/RSV Nucleic Acid Test Card
Guangzhou Pluslife Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
RevoDx Flu A&B / SARS-CoV-2 qPCR Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
Real SARS-CoV-2/Flu/RSV
Operon, S.A.
·
,
Spain
IVD General
CE/IVDD
RevoDx Flu A / Flu B / RSV / SARS-CoV-2 qPCR Kit
İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
Influenza Virus B Typing Real Time RT-PCR Kit
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II
KogeneBiotech Co., Ltd.
·
,
South Korea
IVD General
CE/IVDD
Quadruplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N and Influenza Vi…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
RADI FAST Flu-SC2-RSV Detection Kit
KH Medical Co., Ltd.
·
,
South Korea
IVD General
CE/IVDD
Influenza Virus H1 Real Time RT-PCR Kit
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
COVID-19 Ag Lollypop Rapid Test
GeneSign Biotech (Xiamen)Co., Ltd.
·
,
China
IVD General
CE/IVDD
geneMAP
Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
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