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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry controls/standards/calibrators
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Controls - immunochemistry
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Tumour marker controls
Tumour marker controls
W0102152005
152 devices
VALIDATE® TUMOR MARKERS Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
proGRP Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chemiluminescent Immunoassay Controls for Tumor Marker Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
OC-FIT Control LV1
Eiken Chemical Co., Ltd.
·
,
Japan
Class C
CE/IVDR
Beta2-microglobulin control L
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Carcino-embryonic Antigen Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Tumor Marker Multi Control
Shenzhen Ever-Blue Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Tumor Marker Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Tumor Marker Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Finecare
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
B·R·A·H·M·S CgA II KRYPTOR QC
B.R.A.H.M.S GmbH
·
,
Germany
Class C
FDA 510(k)
K222251
Active
Cleared 18 Sep 2023
CE/IVDR
+1
authorizations
CYFRA21-1 Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Tumor Marker Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
AFP Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
PG I/PG II/G-17 Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Tumour Marker Control II
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Tumor Marker Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Chemiluminescent Immunoassay Controls for Tumor Marker Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Chemiluminescent Immunoassay Controls for Tumor Marker Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
CEA Control
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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