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In vitro diagnostic medical devices
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Infectious diseases
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Infectious immunology - rapid tests & point of care
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Bacteriology - rt & poc
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Strep. a - rt & poc
Strep. a - rt & poc
W0105090103
112 devices
Strep A Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Strep B Antigen Rapid Test Kit (Colloidal gold method)
Nanjing Synthgene Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
TestPack Plus Strep A with OBC
Abbott Diagnostics Medical Co., Ltd.
·
,
Japan
IVD General
CE/IVDD
Group A Streptococcus Detection Kit (Fluorescence PCR)
Hangzhou Danwei Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Exdia Strep A
Precision Biosensor Inc.
·
,
South Korea
IVD General
CE/IVDD
Strep A Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD General
CE/IVDD
Strep A Rapid Test
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Strep A Rapid Test Strip (Throat Swab)
Abon Biopharm(Hangzhou) Co., Ltd
·
,
China
IVD General
CE/IVDD
Strep A Antigen Rapid Test (Immunochromatography)
Qingdao Hightop Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Strep A Rapid Test(Control Line in Red)
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accu-Tell® Strep A Cassette (Throat Swab)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Strep A Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class B
CE/IVDR
IX 2074650-1
Active
Valid to Jun 2029
EuroGen Strep A Rapid Test
GenSure Biotech Inc.
·
,
China
Class C
CE/IVDR
V76 126886 0005
Active
Valid to Jul 2030
RapidFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDR
CE/IVDD
Strep A Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
Clearview® Strep A Cassette 2
Abon Biopharm(Hangzhou) Co., Ltd
·
,
China
IVD General
CE/IVDD
Strep A Rapid Test Cassette (Throat Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Strep A Rapid Test Cassette (Throat Swab)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
dedicio® Strep A Test
nal von minden GmbH
·
,
Germany
IVD General
CE/IVDD
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