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In vitro diagnostic medical devices
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Reagents
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Immunochemistry (immunology)
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Immunochemistry - rapid tests & point of care
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Drugs of abuse/toxicology rt & poc
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Multiple drugs of abuse/toxicology rt & poc
Multiple drugs of abuse/toxicology rt & poc
W0102160511
1,473 devices
S-Trust Multi-Drug Test Dip Card (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Drugs of Abuse Rapid Test Panel
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accu-Tell® Multi-16 Drug Cup W/Alcohol & Adulteration Strip (Urine)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
nal von minden Drug-Screen® Multi 9TC Test
nal von minden GmbH
·
,
Germany
IVD General
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
Pregabalin(PGB) Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class B
CE/IVDR
Multi- Drug Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class B
CE/IVDR
Multi- Drug Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class B
CE/IVDR
Oral Fluid Multi-Drug Test Swab (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi- Drug Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class B
CE/IVDR
Accu-Tell® Multi-3 Drug Dip Card (Urine)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accu-Tell® Multi-4 Drug Dip Card (Urine)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accu-Tell® Multi-Line 8 Drug Cassette (Saliva)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drugs Rapid Test 1-Step Cup
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multi-Drug Test Panel (MOP +5 more)
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
One Step Multi-Drug Screen Test Cup (Urine)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
FDA 510(k)
×4
K163704
Active
Cleared 2 Aug 2017
CE/IVDD
Multi-Drug Rapid Test (Saliva) (MOP +4 more)
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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