BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES
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 of product. The main guiding re...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
National Academy of Sciences of Ukraine and Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine.
2015-04-01
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| Series: | Biotechnologia Acta |
| Subjects: | |
| Online Access: | http://biotechnology.kiev.ua/images/no2_2015/galkin.pdf |