총 101페이지

5. 사용목적, 사용방법 및 사용시 주의사항······················32
1) 사용목적············································································32
2) 사용방법············································································33
3) 사용시 주의사항·······························································35
6. 포장단위, 저장방법 및 사용기한···································36
1) 포장단위············································································36
2) 저장방법 및 사용기한······················································36
7. 시험규격···········································································37
1) 시험항목············································································37
2) 시험기준············································································37
3) 시험방법············································································37
8. 기재사항 및 기타····························································39
Ⅴ. 동물용체외진단시약의 기술문서 심사를 위한
제출자료······································································· 40
1. 개발경위, 측정원리·방법 및 국내?외 사용현황에
관한 자료·········································································44
2. 원재료 및 제조방법에 관한 자료··································44
3. 사용목적에 관한 자료·····················································45
4. 저장방법과 사용기한(유효기한)에 관한 자료···············45
5. 성능에 관한 자료 ··························································45
6. 시약의 취급자 안전에 관한 자료··································47
※ 성능시험에 대한 지침 및 세부 사항·······························48

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