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Immunochemistry (immunology)
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Immunochemistry reagents - other
Immunochemistry reagents - other
W01029099
543 devices
Chemiluminescent Substrate
DiYaLab ZJG Biotech Co., Ltd
·
,
China
Class A
CE/IVDR
Immunoglobulin G (IgG)/Immunoglobulin A (IgA)/Immunoglobulin M (IgM) Detection …
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Creatine Kinase (CK)/Creatine Kinase Isoenzyme MB (CK-MB)/Lactate Dehydrogenase…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Carbohydrate antigen 19-9 (CA19-9) Quantitative Test Kit(Chemiluminescent Immun…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Serum β2-Microglobulin (β2-MG)/Serum Cystatin C (Cys C) Detection Kit (Latex Im…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Gastrin-17 (G-17) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Heart-type Fatty Acid Binding Protein (H-FABP) Detection Kit (Latex Immunoturbi…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Hematoxylin (M)
Guangzhou LBP Medicine Science & Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Beta amyloid protein 1-40 (Aβ1-40) Quantitative Test Kit(Chemiluminescent Immun…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Access Vitamin B12 Reagent Pack
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
K223289
Active
Cleared 23 Dec 2022
CE/IVDR
+1
authorizations
Borg Decloaker, RTU
Biocare Medical, LLC
·
,
United States
Class A
CE/IVDR
GUDID
on market
One Step Dementia Risk Test Kit (Colloidal Gold Lateral Immunochromatography)
Hunan Qankorey Biotechnology Company Ltd.
·
,
China
IVD General
CE/IVDD
Folic Acid (FA) Quantitative Test Kit(Dry Fluorescence Immunochromatographic As…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Adrenocorticotropic hormone (ACTH) Quantitative Test Kit(Chemiluminescent Immun…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Interferon gamma (IFN-γ) Quantitative Test Kit(Chemiluminescent Immunoassay, CL…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Anti-Mullerian hormone (AMH) Quantitative Test Kit(Chemiluminescent Immunoassay…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Serum amyloid A (SAA) Quantitative Test Kit (Dry Fluorescence Immunochromatogra…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Phosphorylated tau217 protein (P-tau217) Quantitative Test Kit(Chemiluminescent…
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Glucose (Glu)/Glycated Serum Albumin (GA) Detection Kit (Enzymatic Method)
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
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