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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 OFT Control Set
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
MDMA Test Kit
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
China
IVD General
CE/IVDD
Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array
Randox Laboratories Limited
·
,
Northern Ireland
Class C
CE/IVDR
CEDIA MultiDrug Optional Controls
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ARK Pregabalin II Assay
Ark Diagnostics Inc
·
,
United States
Class B
CE/IVDR
GUDID
on market
Ketamine (KET) Assay Reagent Kit (CMIA)
Hangzhou Realy Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
THC (Marijuana) Rapid Test (Urine)
Anhui Formaster Biosci Co., Ltd.
·
,
China
IVD General
CE/IVDD
Marijuana (THC) Assay Reagent Kit (CMIA)
Hangzhou Realy Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
CEDIA Multi-Drug Optional Cutoff Calibrator
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
DRI Serum Tox Negative Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CEDIA Multi-Drug High Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Fentanyl FIA
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
ARK Fentanyl II Assay
Ark Diagnostics Inc
·
,
United States
Class B
FDA 510(k)
×2
K200197
Active
Cleared 26 Feb 2020
CE/IVDR
+1
authorizations
Ketamine Test Kit (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step Oxycodone Test Cassette (Urine)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
BAR/BZO/MOP Rapid Test Kit (Colloidal gold method)
Nanjing Synthgene Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
DrugFor™ MDPV Rapid Test Kit (Urine)
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
The Drug Rapid Test (Saliva)
Hangzhou Cybereagen Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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