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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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Drugs of abuse - other
Drugs of abuse - other
W0102090199
307 devices
CEDIA Multi-Drug Calibrator Primary Cutoffs
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Multi-Drug Test Cup XR (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
DoA Control set B
Thermo Fisher Scientific Oy
·
,
Finland
IVD General
CE/IVDD
RapidFor™ MDPV Rapid Test Kit (Urine)
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
The Parent THC Rapid Test Device (Saliva)
Anhui Formaster Biosci Co., Ltd.
·
,
China
IVD General
CE/IVDD
ARK Tramadol Assay
Ark Diagnostics Inc
·
,
United States
Class B
FDA 510(k)
K182280
Active
Cleared 10 Dec 2018
CE/IVDR
+1
authorizations
Kratom Panel Test Drugs of Abuse Test Kit
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class B
CE/IVDR
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Cup XR (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Methamphetamines (MET) Assay Reagent Kit (CMIA)
Hangzhou Cybereagen Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step 3, 4-Methylenedioxypyrovalerone Test Cassette (Urine)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step Tricyclic Antidepressants Test Cassette (Urine)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Card (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Oral Fluid Drug Test Cylinder
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Cup XR (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Ketamine (KET) Rapid Test
Beijing Jinwofu Bioengineering Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ARK Pregabalin II Assay
Ark Diagnostics Inc
·
,
United States
Class B
CE/IVDR
GUDID
on market
Multi-Drug Test Card (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step Multi-Drug Test Dip Card (Urine)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
Oral Fluid Drug Test Cylinder
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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