1、 19001 2013 IN VITRO , in vitro, ISO 19001:2002 In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (IDT) 2014 190012013 II 27 2002 . 184- , 1.02004 . 1 - . . . , 4 2 380 in vitro 3 25 2013 . 1201-. 4 19001:2002 in vi
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4、 multiples and of certain other units) E 375:2001 , in vitro (EN 375:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use) 376:2001 , in vitro (N 376:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing) ,
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6、(stain): , . . 3.6.1 (stock solution of stain): , . . 3.7 (chromogenic reagent): , , , in situ. : ) ; b) . 3.8 (fluorochrome): , . 3.9 (antibody): , - . , . 3.9.1 (polyclonal antibody): , . 3.9.2 (monoclonal antibody): , . 3.10 (nucleic acid probe): , . 3.11 (lectin): , . 190012013 3 4 , 4.1 4.1.1 ,
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