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In vitro diagnostic medical devices
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Clinical chemistry
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Other clinical chemistry
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Clinical chemistry reagents - other
Clinical chemistry reagents - other
W01019099
552 devices
Urinary/CSF Protein
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Total Bilirubin
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
Nucleic Acid Release Reagent (free extraction)
Bioteke Corporation (Wuxi) Co., Ltd.
·
,
China
Class A
CE/IVDR
Superoxide Dismutase (SOD) Test Kit (Pyrogallol Substrate Method)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Odczynnik Pandy'ego 1L
Kolasa Spółka Jawna
·
,
Poland
Class A
CE/IVDR
Redox Ob 10
H & D S.R.L.
·
,
Italy
IVD General
CE/IVDD
25-OH VD Assay Kit (Fluorescence Immunoassay)
DiYaLab ZJG Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
Non-esterified Fatty Acid (NEFA) Test Kit (ACS-PAP)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
HbA1C Hemolysis, 100 x 1 ml, Z
SKALAB s.r.o.
·
,
Czechia
Class A
CE/IVDR
NeoMass CAH Reconstitution Solution
Labsystems Diagnostics Oy
·
,
Finland
IVD General
CE/IVDD
Cleaning solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Odczynnik Nonne-Apelta 100ml
Kolasa Spółka Jawna
·
,
Poland
Class A
CE/IVDR
Capillarys / Minicap Urine
Sebia
·
,
France
Class A
FDA 510(k)
K080916
Active
Cleared 1 Jul 2008
CE/IVDR
CANros
Candore Bioscience
·
,
India
Class A
CE/IVDR
Diluent solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Reagent for removal of DNA contaminations
Genfine Biotech(Changzhou) Co., Ltd
·
,
China
Class A
CE/IVDR
Mitochondrial Aspartate aminotransferase (mAST) Test Kit (Enzyme Inhibition)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cleaning solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Aucheer iMAGIN Trigger Solution
Ningbo Aucheer Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
HbA1C Hemolysis G8
SKALAB s.r.o.
·
,
Czechia
Class A
CE/IVDR
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