Technical requirements for point-of-care testing in vitro diagnostic reagents registration / 中华检验医学杂志
Chinese Journal of Laboratory Medicine
;
(12): 812-816, 2014.
Article
in Chinese
| WPRIM
| ID: wpr-458766
ABSTRACT
POCT in vitro diagnostic reagents featuring with easy operation , on-site testing, low requirements for specimen processing , fast results , usually applied small testing equipment , is a strong complement to high-throughput , large automated tests in clinical laboratory centers.According to the State Council issued in 2014 “Supervision and Regulation of Medical Devices ” and series regulations and management practices issued by the China Food and Drug Administration , conduct an investigation in POCT IVD registration relevant technical requirements and give some advice for the relevant personnel of register work.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Diagnostic study
Language:
Chinese
Journal:
Chinese Journal of Laboratory Medicine
Year:
2014
Type:
Article
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