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In vitro diagnostic medical devices
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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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Benzodiazepines
Benzodiazepines
W0102090104
35 devices
Devices
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
CN
IVD General
CE/MDR
Clonazepam (CLO) Rapid Test
Zhejiang Greylynx Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
ARK HS Benzodiazepine II Assay
Ark Diagnostics Inc
·
,
US
Class B
CE/IVDR
GUDID
on market
DRI Benzodiazepine Assay
Microgenics Corporation
·
,
US
IVD General
FDA 510(k)
K173963
Active
Cleared 21 Feb 2018
CE/IVDD
+1
authorizations
Benzodiazepine (BZO) Assay Reagent Kit (CMIA)
Hangzhou Realy Tech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Benzodiazepine (BZO) Assay Reagent Kit (CMIA)
Hangzhou Cybereagen Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
DRI Benzodiazepine
Instrumentation Laboratory SpA
·
,
IT
Class B
CE/IVDR
CEDIA Benzodiazepine Assay
Microgenics Corporation
·
,
US
IVD General
FDA 510(k)
K190968
Active
Cleared 9 Dec 2019
CE/IVDD
+1
authorizations
ARCHITECT Benzodiazepines
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
CEDIA Benzodiazepines Assay
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Benzodiazepines
Thermo Fisher Scientific Oy
·
,
FI
IVD General
CE/IVDD
Alinity c Benzodiazepines SemiQuant Calibrator
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
DRI Benzodiazepine Assay
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
CN
IVD General
CE/IVDD
ClinMass®
RECIPE Chemicals + Instruments GmbH
·
,
DE
IVD General
CE/IVDD
DRI Benzodiazepine Serum Tox Assay
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Benzodiazepine Reagent (BNZG 1 x 250)
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Alinity c Benzodiazepines Qual Calibrator
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
Benzodiazepines (BZO) Rapid Test
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Benzodiazepines (BZO) Rapid Test
Beijing Jinwofu Bioengineering Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
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