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Immunochemistry (immunology)
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Drugs of abuse / toxicology
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Drugs of abuse
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Cocaine + cocaine metabolites
Cocaine + cocaine metabolites
W0102090106
29 devices
Devices
COC (Cocaine) Rapid Test (Urine)
Anhui Formaster Biosci Co., Ltd.
·
,
CN
IVD General
CE/IVDD
DRI Cocaine Metabolite Assay
Microgenics Corporation
·
,
US
IVD General
FDA 510(k)
K211973
Active
Cleared 24 Sep 2021
FDA 510(k)
K181499
Active
Cleared 6 Jul 2018
+2
authorizations
Cocaine（COC）Assay Reagent Kit (CMIA)
Hangzhou Realy Tech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Cocaine Metabolite Reagent (COCM 1 x 250)
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
COC Rapid Test Kit (Colloidal gold method)
Nanjing Synthgene Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
CEDIA DAU Cocaine
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
CEDIA Cocaine OFT Assay LC
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Cocaine (COC) Rapid Test (Urine)
Hangzhou Immuno Biotech Co., Ltd
·
,
CN
IVD General
CE/IVDD
Cocaine Panel Test Drugs of Abuse Test Kit
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
CN
Class B
CE/IVDR
Singclean®
Hangzhou Singclean Medical Products Co., Ltd.
·
,
CN
IVD General
CE/MDR
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
CN
IVD General
CE/MDR
DRI Cocaine Metabolite
Instrumentation Laboratory SpA
·
,
IT
Class B
CE/IVDR
NarcoCheck Cocaine urine rapid test
Kappa City Biotech
·
,
FR
IVD General
CE/IVDD
COC (Cocaine) Rapid Test (Saliva)
Anhui Formaster Biosci Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Cocaine (COC) Rapid Test
Beijing Jinwofu Bioengineering Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Cocaine(COC)Assay Reagent Kit (CMIA)
Hangzhou Cybereagen Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
DRI Cocaine Metabolite Assay
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
One Step COC Rapid Test
Zhejiang Anji Saianfu Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Alinity c Cocaine
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
CEDIA Cocaine Assay
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
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