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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
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Haemostasis reagents (coagulation)
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Coagulation inhibitors/thrombophilia markers
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Lupus anticoagulant
Lupus anticoagulant
W0103020606
26 devices
Devices
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/MDR
sthemO dRVV confirm
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
HemosIL Silica Clotting Time
Instrumentation Laboratory Company
·
,
US
Class B
FDA 510(k)
K160445
Active
Cleared 16 Mar 2016
FDA 510(k)
K050221
Active
Cleared 30 Mar 2005
+2
authorizations
TriniCLOT Lupus Confirm
Tcoag ireland ltd
·
,
IE
IVD General
CE/IVDD
HemosIL dRVVT Screen
Instrumentation Laboratory Company
·
,
US
Class B
CE/IVDR
GUDID
on market
sthemO dRVV screen L
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
HemosIL dRVVT Confirm
Instrumentation Laboratory Company
·
,
US
Class B
CE/IVDR
GUDID
on market
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
STA® - Staclot® dRVV Screen 2
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
GUDID
on market
Atlas SLE Latex, 50 Tests
Atlas Medical GmbH
·
,
DE
IVD General
CE/IVDD
STA® - Staclot® dRVV Screen 5
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
GUDID
on market
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
W0103020606
Tcoag ireland ltd
·
,
IE
IVD General
CE/IVDD
Lupus Anticoagulant Assay Kit (Coagulation Method)
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
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