Hepatocellular Carcinoma Risk Assessment, Des-Gamma-Carboxy-Prothrombin (Dcp) Suppliers
EMAIL INQUIRY to 1 suppliers
Wako Diagnostics | Address: 1600 Bellwood Road, Richmond, Virginia 23237, USA 
www.wakousa.com | Send Inquiry | Phone: +1-(804)-714-1924
FDA Registration: 1627434 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001 Certified
Products: C-Reactive Protein (CRP), General Chemistry Calibrators, General Chemistry Test Kits, Cardiac Markers kits, Immunoassays, Lipids Test Kits, ...
Wako Diagnostics develops high purity chemicals. We are an ISO 9001 certified company. We are a comprehensive manufacturer of clinical diagnostic reagents that are of highest quality and extremely cos more...
www.wakousa.com | Send Inquiry | Phone: +1-(804)-714-1924
FDA Registration: 1627434 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001 Certified
Products: C-Reactive Protein (CRP), General Chemistry Calibrators, General Chemistry Test Kits, Cardiac Markers kits, Immunoassays, Lipids Test Kits, ...
Wako Diagnostics develops high purity chemicals. We are an ISO 9001 certified company. We are a comprehensive manufacturer of clinical diagnostic reagents that are of highest quality and extremely cos more...
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EMAIL INQUIRY to 1 Hepatocellular Carcinoma Risk Assessment, Des-Gamma-Carboxy-Prothrombin (Dcp) suppliers
FDA Code / Regulation: OAU / 866.6030
An AFP-L3% immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure, by immunochemical techniques, AFP and AFP-L3 subfraction in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma, in conjunction with other laboratory findings, imaging studies, and clinical assessment.
Classification. Class II (special controls). The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems." See 866.1(e) for the availability of this guidance document.
