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In vitro diagnostic medical devices
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Reagents
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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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Opiates
Opiates
W0102090113
53 devices
Alinity c Opiates Semiquant Calibrator Kit
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
CEDIA Heroin Metabolite (6-AM) Cutoff-Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ARCHITECT Opiates 1000 Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
ARCHITECT Opiates Reagent Kit
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
Atlas
Atlas Medical GmbH
·
,
Germany
IVD General
CE/IVDD
CEDIA Opiate OFT Assay_LC
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Opiates
Thermo Fisher Scientific Oy
·
,
Finland
IVD General
CE/IVDD
Alinity c Opiates Assay
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
Meperidine Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
ARCHITECT Opiates 300 Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
DRI Hydrocodone Assay Control Kit (2 x 10 mL)
Microgenics Corporation
·
,
United States
IVD General
FDA 510(k)
K173195
Active
Cleared 13 Feb 2018
CE/IVDD
+1
authorizations
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