イ本外診断用医薬品の承認基準の制定につし丶て 団地
Contents
1.2.
3.
4. 4 1 1 16 169
5. 2 3
6. 2
7. 17 2 16 0216004 17 2 16 0216005 JIS T 14971 JIS T 14971
8. JIS T 1497i 17 2 16 0216004 17 2 16 0216005 16 169
9. 6 169 1 17 2 16 0216004 I7 2 16 0216005 16 169
10. 17 2 16 0216004 17 2 16 0216005 JIST 14971 4 17 2 16 0216004 17 2 16 0216005 5
11. JCTLM Joint Committee on Traceability in Laboratory Medicine NCCLS National Committee for Ciinical Laboratory Standards JCCLS Jananese Committee for Clinical Laboratory Standards 3 1 mxn 2 X Y X Y 4
12. IVD uk CU 17 2 16 0216004 IVD 1 2 SD 3
13. 2 _ 10 JIST 14971 17 2 16 0216004 17 2 16 0216005 17 3 10 0310006 17 3 31 0331014
14. 09
15. 17 2 6 0216005 lt ili 30539000 2 2 44562003 3 CF 2 3 rie ET 84026000 Li tCEA 30288009 AFP 3029500 IAFP 43480000 AFP L3 8 FL 44440000 ICA125 aa aoc sy 125 CA125 CAGD2 43034000 6D2 2 I Pr 0
16. JIS T 14971 17 2 16 0216004 17 2 ie 0216005 JIST 1497t 17 2 16 0216004 17 2 16 0216005 JIS T 14971 17 2 16 0216004
17. 1 H ITV HCVY DV HTLV 1 1 2 3 90 2 1 2 3 0 9 0 9 1 1
18. 17 2 16 0216005 16 169 Ds JIS T 14971 17
19. 16 169 JIS T 14971 17 2 16 0216003 17 2 16 0216005 JIS T 14971 17 2 6 0216004 17 2 16 0216005
20. 17 2 16 0216005 JIS T 1497 SS 5 4 5
21. 17 6 22 0622006 17 2 16 0216004 2
22. JiS T 14971 17 2 16 0216004 17 2 le 0216005 JIS T 14971 17 2 16 0216004 17 2 Ie 0216005 JIS T 14971 3
23. D 1 30717000 Weit Felix 4925D000 44428000 HI CF ee 1 397746000 37748000 pi 37741000 mn 30818000 I lgM 30818000 M I 2 ms Tcl rwsmw ml IgG 30817000 G n 80819000 30700000 a a G157 ee ri 44030000 H7 I 42845000 1
24. A bd pd A 43228000 32437000 RS RS IRS 30814000 RS 13 3 a 44008000 I 440f9000 XIgG 84009000 27U gt G 2 HU EM 684025009 AM rn 37740000 TXTHLXIFG lgM FE Sys SV5
25. 14 96 2 14 1 19 2 1 IVD 4 4 17 6 16 0616001
26. 16 169 17 2 16 0216004 17 2 6 0216005 16 169 JIST14971 17 3 10 0310006 17 3 31 0331014
27. 17 3 31 0331014 17 3 10 0310006 17 3 31 0331014 17 2 16 0216004
28. nm _ A 43175000 A 8 ai 37758000 43193000 44443000 MRSA TSST 1 TSST 1 1 g B KHBc B HBs B HBe HPV 30628003 1 KAAOT AFP ER CEA
29. 17 3 10 4 2 16 169 a os
30. 0157LPS 44025000 157LPS 3 D 43226000 1 3 228 gt E Coli k1 C 2 7 IM b 7 44188000 I A G IW135 9 A Y 2 44029000 j 2 mm 44203000 I 7t7 30713000 G 7 2MgG 44202000 A 10 2 30702000 44020000
31. 17 2 16 0216004 3 so 17 2 16 0216005 32 6 10 167 17 3 10 0310006 17 3 31 0331014
32. 44201000 30692000 11 3 mm lee seew ma Pin HBA 30720000 IA un G HAv gM HAY 30722000 IA M Be 30731009 un eM HBc 30733000 Pac aso HBe 30734000 m IhBe 907S7000 HB HB e 36047000 a gt Ha 320725000 lprw S2 44200000 pra SZ HE 8 ugs 44199000 MEF Ay 40 741 41274000 CF ri 30805000
33. 2 2 Y 0 WHO JCTLM NCCLS JCCLS
34. 1 43237000 1 I EmB 2 c er6B HER2 c e 43270000 IErbB 2 J Le CSLEX 42825000 1 Le 7 27 22 43197000 2 NMP2 1 C PICP 42822000 1 T 1 C FCtCTP 42941000 i HI 1 N ea NT 43289000 1 I PDA 44433000 POA I 1 BTA E R 30233000 ER 38217000 gt gt DPD 30348000 LCAP 44254011 S
35. 253 gt n HL 3 J I i a 2 21 gt 0043008 E0047003 gt Py 80049003 20952008 SL 80054003 m HI1V HCV HDV HTLV
36. HCG 43456000 1 6 PA ad Pa MRSA MRSA ao 8 code 44455000 33361000 30656003 44378000 431f62000 44408003 4440
37. 0622006 7 6 22 14 7 14 96 2 35 145 15 12 15 534 17 4 1 14 1 19 2 1 14 9 19 2 5
38. 3402700D 2 76000 CF 75000 lgG ek jgG gA tgA 979000 igM Le 30881000 gM 30493000 A A SP 44024000 ONass 30491000 30492000 8 A 8 44031000 A 30682000 42947000 Wida 440280D0 1 2 ka 30689000 44204000 mI Pe
39. AP 36010010 HI 34226000 1 PA PSA 332g6000 i 7 37287000 w 1 RS 43145000 NSE 30301000 1 Man leo en EC GAT 43185000 1 GAT I 1 SP1 44325000 1 gt I 44379003 lprvka 19 30287000 19 ri 9 2 ProGRPt3t 88 4443B000 1 ICAS4 61 43196000 4 5 1
40. 0310006 17 3 31 0331014 16 169 JIS T 14971 17 2 16 0216004 17 2 16 0216005 IE 32 6 10 167 6 169 JIST 14971
41. 7 g RA 30806000 NR A CF pe 305G4000 2 Hu 1 AT 30802003 1 1 u 2 2 Pa 2 30802013 jie 41759013 G 1e000 M 44027000 2 3 ade 2 30797000 E BB EB CEBNA 30809000 fB tgG IEB EA lgG IEB v CA lgG IEB VCADMrG
42. 43009000 SV5 HH SV41 VAt 43955000 ISV41 I y 30811000 I 38877003 1 19HgG 819 39877013 FE ITgtM aa73029 819 M 14 3 E C c RHa D E e C Rh Hr 4 30597000 30588000 43111000 43113000 30608000 30612000 BO Rh 1 1 5 i 30515003 3 E3G 43148003 Er FbOE
43. 3 4 4 1 1 2 100 50
44. 2 3 JIS 14971 17 2 16 0216004 17 2 16 0216005 JIS T 14971 1 17 2 16 0216004
45. 1 PSA 30628023 1 PSAP PSAP PAP NSE E 2 HER2 nau 30828033 20 ete ett 80004003 soooyoos a 80010093 6 6003 a go019003 i 80021003 ee fa ca goo25o03 a 80031003 9094004 gt Co nm fi I
46. 6 22 0622006 17 2 16 0216004 17 2 te 0216005 16 169 2 3 JIS T 14971
47. 43150000 130 CA15 3 CA15 3 30279000 15 3 IH F 1C 15 3 BCA225 43825000 BCA225 IA19 B CA19 8 CA 30280000 19 9 19 9 CA19 9 5O CA50 3028f000 50 I CA72 4 CA72 4 30282000 72 4 Tn CSTN 43306000 Tn 1 KMO1 1 43309090 KMO1 wh IDUPAN 2 43308000 IDUPAN 2 hl Ls SLX 43824000 Le I Ncc sT 439 43307000 NCC ST 439 1 SPan 1 43623000 SPan 30291000 SCC il Sm 43428000 zz F TPA 30292000 1 I TPA
48. IEB EENA lgG G B4008000 EB lgA EH CV CA fgA IEB 84907000 A TA NR RT VCAJ1gA IEB CEBNA EB MM EBNAD 93902000 IM tvCAJlgM IEB CA lgM A 7731000 37729000 lgG IgM A
49. 8013 306S4000 30710000 1 3 2 I I MRSA 2 E gt 2 2 Hu eo 86904000 lb 30707000 37725000 J gE 37727000 30718000 0 I 37752000 I C 3250B000 a Pe a 30705000 a Le JJ 42957000 32504000 I 49353000
50. JiS T 14971 17 2 16 0216004 17 2 16 0216005 3 JIS T 14971 _ 17 2 16 0216004 17 2 16 0216005 17 3 0 0310006
51. as gt A gt 2 2 TT i weww ml IgG 30g91000 30 16000 TP 30887000 TPigM 44428000 32450000 20g97000 I mT a a ey RI ME 30704000 A 30714000 hn
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