PDFファイル - 医薬品医療機器総合機構
Contents
1. UniCel Dxl 800 1 1 27 19 26mlU mL 3 85 8 78mlU mL 1 79 5 12mlU mL 16 74 113 59mlU mL 2 1 S5 S5 S0 1 12. 3 A23909 1 2 3 81901 386167 4 1 FSH S0 S5 6 2
3. hFSH R1c PPD R2 4 4 3 1 2 3 2 2 R3 so S1 82 83 84 FSH 1 10 50 100 200 mlU mL S5 FSH FSH FSH FSH FSH hFSH hFSH PPD PPD
4. 2 3 4 5 6 2 2 REO 2 R1 FSH 2 10 C 24 R2 2 8 C 12 a R1 33
5. eS 2 3 HIV HBV HCV 2 4 5 ProClin 300 2 1
6. Dxl 800 600 Dxl A 1 1 2 Dxl 800 600 170mIlU mL 3 HAMA NE 7 FSH w 3 hFSH hFSH Gn RH
7. FSH FSH 1 2 3 4 5 2 500 gL 15 30 C 8 8 2 8 C 48 20C 3 1 6
8. 33520 Wa COULTER 2013 12 2 2011 12 1 13A2X00150000096 FSH 1 2 3 4 Access Access2 Synchron LXi 725 UniCel Dxl 800 600 1 R1 lgG R1a hFSH R1b
9. 345e hFSH hLH hFSH 9 FSH Gn RH 17 18 20 hFSH 1mlU mL A 0mlU mL B AB 1 7 3 5 5 2SD 2SD 209 4 54 22 51mIlU mL 5 109 0 2 lt 200mlU mL N 161 Y 0 95X 1 98 r 0 977 X EIA WHO2 IRP 78 549
10. 7 8 1 25 L Dxl 800 600 1 155L 9 mlU mL SI IU L SI mlU mL 1 10 1 2 3 4 10mg dL 1 000mg dL
11. 28 2 25 L Amax 540nm FSH 55 5 1 2 3 2 1 1
12. 1 800mg dL 3qg gL 1 0 10 C 28 4 2 2 10 C 15 30C 18 14 2 R3 ie 15 30 C S0 85 2 10 C
13. Kricka L Interferences in Immunoassays Still a Threat Clin Chem 2000 46 1037 6 Bjerner J et al Immunometric Assay Interference Incidence and Prevention Clin Chem 2002 48 613 621 7 Krouwer JS Rabinowitz R How to improve estimates of imprecision Clinical Chemistry 1984 30 290 292 8 Tentative Guideline User evaluation of precision performance of clinical chemistry devices EP5 T 1984 National Committee for Clinical Laboratory Standards 4 No 8 9 HHS Publication 4th ed April 1999 Biosafety in Microbiological and Biomedical Laboratories Available http Www cdc gov od ohs biosfty bmbI4 bmbI4toc htm 20 IFU_2010_A83734B 135 0063 5 7 TOC TEL 0120 566 730 FAX 03 5530 2460 135 0063 5 7 TOC 33520_1312
14. 520 FSH 50 x2 R2 81906 130mLx4 A16792 1 950mLx4 R3 A16793 UniCel Dxl 800 10L S0 S5 33525 FSH 4mL 81908 4mLx1 A79783 Dxl A 32 9mL x2 Vaitukaitis JL and Ross GT Antigenic similarities among the human glycoprotein hormones and their subunits In Gonadotropins 1972 Edited by Saxena BB Gandy HM and Beling CG New York NY John Wiley and Sons 435 443 2 Pierce JG and Parsons TF Glycoprotein hormones structure and function Annual Review of Biochemistry 1981 50 465 495 3 South SA Yankov Vl and Evans WS Normal reproductive neuroendocrinology in the female In Endocrinolgy and Metabolism Clinics of North America Edited by Veldhuis JD Philadelphia PA WB Saunders Co 1993 22 1 28 4 Adashi EY The ovarian life cycle In Reproductive Endocrinology Edited by Yen SSC and Jaffe RB Philadelphia PA WB Saunders Co 1992 22 1 28 5 Yen SSC The human menstrual cycle neuroendocrine regulation In Reproductive Endocrinology Edited by Yen SSC and Jaffe RB Philadelphia PA W B Saunders Co 1991 273 308 6 Richardson SJ The biological bas
15. is of menopause Baillieres Clinical Endocrinology and Metabolism 1993 7 1 16 7 Reyes Fuentes A and Veldhuis JD Neuroendocrine physiology of the normal male gonadal axis In Endocrinology and Metabolism Clinics of North America Edited by Veldhuis JD Philadelphia PA W B Saunders Co 1993 22 93 124 8 Carr BR Disorders of the ovary and female reproductive tract In Wiliams Textbook of Endocrinology 8th edition Edited by Wilson JD and Foster DW Philadelphia PA WB Saunders Co 1992 733 798 9 Hall JE Polycystic ovarian disease as a neuroendocrine disorder of the female reproductive axis In Endocrinology and Metabolism Clinics of North America Neuroendocrinology Il Edited by Veldhuis JD Philadelphia PA WB Saunders Co 1993 75 92 0 Bonnar J The hypothalamus and reproductive function In The Medical Annual Edited by Scott RB and Walker RM Bristol England J Wright and Sons 1973 251 258 1 Tietz Textbook of Clinical Chemistry 2nd edition Edited by Burtis CA and Ashwood ER Philadelphia PA WB Saunders Co 1994 1846 1850 2 DHHS NIOSH Publication No 78 127 August 1976 Current Intelligence Bulletin 13 Explosive Azide Hazard Available http Wwww cdc gov niosh 3 Approved Guideline Procedures for the Handling and Processing of Blood Specimens H18 A3 2004 Clinical and Laboratory Standards Institute 4 Cembrowski GS Carey RN Laboratory Quality Management QC QA ASCP Press Chicago IL 1989 5
Download Pdf Manuals
Related Search