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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
SYNCHRON Systems 75 ng/mL THC Urine Control
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Thyroid autoantibodies Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Serum Bone Marker Level 1 Control (Serum Bone Marker Control 1)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
B·R·A·H·M·S sFlt-1 KRYPTOR QC
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
GUDID
on market
ImmunoCAP Specific IgE Control H
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Strep A Control
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
PCT Control
Heavybio, Inc
·
,
China
IVD General
CE/IVDD
Dengue NS1 Ag Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
CRP Control
Heavybio, Inc
·
,
China
IVD General
CE/IVDD
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
D-dimer Control
Coei Biotech Co.Ltd.
·
,
China
IVD General
CE/IVDD
Thyroid Autoantibodies Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
nDNA POSITIVE CONTROL
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Access Inhibin A (QC)
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
VivaDiag Procalcitonin Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
IDS Positive Specific IgE Control (G006) Timothy Grass
Immunodiagnostic Systems Limited
·
,
United Kingdom
IVD General
CE/IVDD
Thyroid autoantibodies Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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