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C.difficile gdh and toxin a/b combined detection
C.difficile gdh and toxin a/b combined detection
W0105011803
8 devices
Devices
C. difficile Toxin B FIA
Assure Tech. (Hangzhou) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
C. Diff Quik Chek Complete
Techlab, Inc.
·
,
US
Class B
FDA 510(k)
K053572
Active
Cleared 26 Apr 2006
FDA 510(k)
K082499
Active
Cleared 26 Mar 2009
+2
authorizations
mariPOC® CDI test plate
ArcDia International Oy Ltd
·
,
FI
IVD General
CE/IVDD
Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
C. difficile GDH & Toxin A/B Combo Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
CN
IVD General
CE/IVDD
RapidFor™
Vitrosens Biotechnology Inc.
·
,
TR
IVD General
CE/IVDD
C. difficile GDH & Toxin A+B Combo Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
CN
IVD General
CE/IVDD
C. difficile Toxin A FIA
Assure Tech. (Hangzhou) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
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