BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

Article English OPEN
A. Yu. Galkin ; A. G. Komar ; A. A. Grigorenko (2015)
  • Publisher: National Academy of Sciences of Ukraine and Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine.
  • Journal: Biotechnologia Acta (issn: 2410-7751, eissn: 2410-776X)
  • Related identifiers: doi: 10.15407/biotech8.02.112
  • Subject: in vitro diagnostics | serological methods | analytical methods | standardization | validation | Biotechnology | TP248.13-248.65

In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type o... View more
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