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Immunochemistry (immunology)
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Drugs of abuse
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Opiates
Opiates
W0102090113
53 devices
CEDUA DAU Opiate 2K
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Carfentanyl Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
RapidFor™ OPI Detection Kit (Saliva) (FIA)
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
Opiates (OPI) Assay Reagent Kit (CMIA)
Hangzhou Cybereagen Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
ARCHITECT Opiates 150 Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
Opiates (OPI) Assay Reagent Kit (CMIA)
Hangzhou Realy Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
CEDIA DAU Opiate
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
DRI Opiate Assay
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
DRI Hydrocodone Assay
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Opiate 300 ng Reagent (OP 1 x 250)
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
DRI Opiate Assay
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Fentanyl (FTY) Test Dip Card 20 (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
DRI Hydrocodone Calibrator 500
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation
·
,
United States
IVD General
FDA 510(k)
×3
K192943
Active
Cleared 16 Dec 2019
CE/IVDD
+1
authorizations
DRI Opiate Urine Calibrator 3
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
DRI Opiate Assay
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Opiates (OPI) Rapid Test (Urine)
Hangzhou Immuno Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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