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2、medical devices for fluorescent and immunofluorescent analysis of dried spot of newborns blood.Part 2. onsumables (kits of reagents) for fluorescent and immunofluorescent analysis of dried spot of newborns blood.Technical requirements for state to buy in 201506011 - ( ) - in vitro : , , - , , . - (
3、), , - (. 55992.12014)2 : 5108897 . - 55992.12014 in vitro . 1. - -. 136402010 in vitro 136122010 - in vitro 136412010 , - in vitro 175112006 in vitro. . , 181532006 in vitro. . , 151932007 in vitro. . 1 55992.22014 149712009 . - - , 1 , - . - , , . , - , (). , , , , , . , -, , , .3 , 3. ISO 18113.1
4、5, 3 55992.1, - :3.1 in vitro (in vitro diagnostic reagent): , , , in vitro. 7, 3.9.3.2 (kit): (), , in vitro - ( ), ( ), . , in vitro.1 , , , , , .2 5108897, 3.1, 7, 3.10.3.3 (performance characteristic, metrological property): , - in vitro. , , . , , in vitro - .3.4 (performance claim): - in vitro
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6、 :- , - ;- .3 3, 4.19.3.9 (diagnostic sensitivity): - in vitro , .1 , . in vitro .13.2 ( , 0 100), - () 100 - () - () , 100c180/( + ). - , .3 5, .3.55 , - .4 8, 4.5.1.3.10 (diagnostic specificity): - in vitro - 5, 3.16.1 , , , -. - in vitro . 5.2 ( , 100), - 100, - () , - () - () 100 c180 /( + ). , .3 , - 5, .3.55.4 8, 4.5.1.3 55992.220143.11 (specimen): , . , , - . 2, 3.5.3.12 (analytical portion): , , . 151932007, 3.4. , .
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