Technical requirements of the pathogen-specific IgM qualitative detection reagents / 中华检验医学杂志
Chinese Journal of Laboratory Medicine
;
(12): 947-949, 2013.
Article
in Chinese
| WPRIM
| ID: wpr-442216
ABSTRACT
To offer the guidance of the registration application of in vitro diagnostic (IVD) reagents,the technical requirements for registration of the pathogen-specific Immunoglobulin M (IgM) qualitative test reagents were discussed.The application paperwork including the evaluation of analytical performance was analyzed based on the the legal requirement from the China Food and Drug Administration (CFDA)and the experience of the IVD registration.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Diagnostic study
/
Practice guideline
/
Qualitative research
Language:
Chinese
Journal:
Chinese Journal of Laboratory Medicine
Year:
2013
Type:
Article
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