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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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Controls- immunochemistry - other
Controls- immunochemistry - other
W0102152099
219 devices
HAV IgM (Liquid) Control
Xiamen Innodx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
B·R·A·H·M·S MR-proADM KRYPTOR QC
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
tIgE Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
nDNA POSITIVE CONTROL
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
IDS Negative Specific IgE Control (F003 / G006) Cod / Timothy Grass
Immunodiagnostic Systems Limited
·
,
United Kingdom
IVD General
CE/IVDD
ImmunoCAP Total IgE Control LMH
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
IDS-iSYS 1, 25 VitDXp Control Set
Immunodiagnostic Systems Limited
·
,
United Kingdom
IVD General
CE/IVDD
SYNCHRON Systems ETOH Calibrator
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Tuberculosis Antigen Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
IDS Beta CrossLaps® (CTX-I) Control Set
Immunodiagnostic Systems Limited
·
,
United Kingdom
Class B
CE/IVDR
GUDID
on market
Vigil Serology Control Level 2
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
D-Dimer Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
β2-Microglobulin Control
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
HA Control Set
Fujifilm Wako Pure Chemical Corporation
·
,
Japan
Class B
CE/IVDR
iPTH Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Kemilo IL-6 Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
IMMULITE D-Dimer Control Module
Siemens Healthcare Diagnostics Products Limited
·
,
United Kingdom
Class C
CE/IVDR
ImmunoCAP Specific IgG/IgG4 Control L
Phadia AB
·
,
Sweden
Class B
CE/IVDR
Lkm Positive Control
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Access IL-6 (Quality Control)
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
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