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In vitro diagnostic medical devices
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Multiple parameters - (infect. immunology/nat)
Multiple parameters - (infect. immunology/nat)
W010507
1,235 devices
Subcategories
5
W01050702
Multiple bacteria / fungi panels
118
devices
›
W01050703
Multiple viruses panels
263
devices
›
W01050704
Multiple parasites panels
18
devices
W01050705
Multiple panels for infections - various
817
devices
›
W01050799
Multiple viruses - other
19
devices
Devices
Influenza Virus A&B Real Time RT-PCR Kit
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
N7 Gene of Influenza Virus A Real Time RT-PCR Kit
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
PlexPCR RespiVirus (610)
SpeeDx Pty. Ltd.
·
,
Australia
Class B
CE/IVDR
SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Influenza A/B Antigen Rapid Test
GeneSign Biotech (Xiamen)Co., Ltd.
·
,
China
IVD General
CE/IVDD
TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit
3B BlackBio Dx Limited
·
,
India
Class B
CE/IVDR
Quadruplex Real-Time PCR Diagnostic Kit for Rapid Detection of 2019-nCoV and In…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Detection Kit (Fluorescence RT-PCR)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
SARS-CoV-2 & Influenza A/B Detection Kit (Fluorescence PCR)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Cowingene Respiratory Pathogen Panel Pro Detection Kit
Taizhou Cowingene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-2-CoV (Covid-19)/ Influenza A Virus/ Influenza B Virus/ Respiratory Syncyt…
Igenesis(Shanghai)Co., Ltd.
·
,
China
IVD General
CE/IVDD
6 RP Panel II
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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
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