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Drugs of abuse - other
Drugs of abuse - other
W0102090199
307 devices
One Step Multi-Drug Screen Test Vacuum Cup (Urine)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Methcathinone (CATH) Assay Reagent Kit (CMIA)
Hangzhou Cybereagen Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Card (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step Drugs of Abuse Test Strip (Urine)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Cup SE (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step Opiate Test Strip (Urine)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Cup PLUS (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
DRI 300 mg/dL Alcohol Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
The Drug Rapid Test (Saliva)
Hangzhou Realy Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Ketamine (KET) Assay Reagent Kit (CMIA)
Hangzhou Cybereagen Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-drug Combined Rapid Test Cassette (Colloidal Gold Method)
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Cup PLUS (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Card (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Card (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
THC+MET combo Rapid Test
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
ARK EDDP Assay
Ark Diagnostics Inc
·
,
United States
Class B
CE/IVDR
GUDID
on market
DRI pH Detect Test
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Multi-Drug Test Cup SE (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ARK EDDP Assay
Ark Diagnostics Inc
·
,
United States
Class B
FDA 510(k)
K182779
Active
Cleared 21 Nov 2018
CE/IVDR
+1
authorizations
One Step UR-144 Test Cassette (Urine)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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