体外診断用医薬品の認証基準の制定について（PDF：1121KB）
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1. lt 2 3 J JIST 14971 UW j X VW VW VTT WA 17 3 31 0331033 eid lan J 17 3 31 0331010 32. Ws Vs O DO Wn J W oo 0331033 UL OV YY 17 3 31 0331010 JIST 14971 Xx DD PVA 17 3 31 0331033 D DOVYT 17 3 31 0331010
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9. D PP 5 V 16 169 V U5 L lt t ve 7 a JIST 14971 JJ gt EE OWT 17 3 31 0331033 DV 17 3 31 0331010
10. TV JCTLM Joint Committee on Traceability in Laboratory Medicine NCCLS National Committee for Clinical Laboratory Standards JCCLS Japanese Committee for Clinical Laboratory Standards 3 L L 1 V D m Xn L 2 0 X Y 4 y
11. Vv D UT 2 L 2 DY 0 LE W WHO JCTLM NCCLS JCCLS LT L lt OD L LTW VW V UV T CV WW
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15. 0331033 UL DV 17 3 31 0331010 JIST 14971 J XX J W 2 WS Vv V V i VW 17 3 31 0331033
16. gt TI IG F 1 30359000 gt I yh yc FT gt JU gt 1 JIGFBP 1 30361000 T gt UV gt 1 1 gt JJ gt wk 1 IGFBP 1 gt gt 3 s tGFBP 3 i 2 F324 PRL hzn32 gt PRU 30357000 j gt S 1 ACTH 44329000 YFL yy w I 3 gt T3 uptake 30313000 J9 wy 1 TS T3 uptake 3 gt U gt y 30316000 gt U 2 1 TBG gt TBC 43297000 gt 1 PTH 4 PTH gt xx PTH C A 57 30854000 wt 1 F3535 2 KPTH M 1 4 F35
17. BA2 1I0IRFYY RB2 mm B2 31I070FY B MG B 2 S2D5DU gt BR 2 rm YL ME 30190002 gt gt Y gt gt gt FAGTP 38507002 30191002 30327012 ww 44399000 gt U gt G D U gt G IgG UvA TIEA 1 30228002 A ww U gt G IgEM 30234002 U gt M gt 2 JU gt lt UA 30183002 wt UN 42849002 C Az KR CPR 30336002 C K 43378002 L7 gt s 38541012 AY yk 43049000 wy F FFD FSH 30329002 Q1 7 gt FU 32268002 EIDEY FFXTIY 81001000 bd 2 PLT 41755000 I Metnoa wo ew poe eat peta
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23. L gt IEE UL 27 Hi 44 E 30236000 A 1 4 ey ee sayozuvaaeuc ed EA IgM L yi L 84021000 wt EH Me CHso 43254000 CHso I a EE nie esa a Be es Es mean et ee es we ee Re 1 1 gt I ecTnI gt TITnT F gt gt gt AT gt F747 gt J 43373000 Y 3 wy gt 7S 44293000 33 7S w FUY2 X 3 MMP 3 s gt L UU gt A SP A 44398000 44155000 2 X 6 4 ANA 30454000 gt I ey Re El ee Pt A 44308000 EF X w 1 1J
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27. 0622004 17 6 22 14 7 O 14 96 2 i 35 145 L amp W WA 15 12 15 534 0 17 4 1 9 23 2 5 23 DD 2 4 lt pe OWT D 9 5 L DP T D WL V D
28. 0 i D WW 4 VV VW lt 16 169 16 169 tebe Bd 17 3 31 0331033 WwWT 17 3 31 0331010
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36. 2 5A 42890000 12 5 I i 44229000 7D ULERD _ 1 1 Se 43378000 E PA et 38542000 2 gt gt 1 a 33647000 5 1 35 gt TFT53 DE 83002000 gt gt 1 2 NPN 44178000 I ee i ge 44179000 Ri a 44176000 Be ee eg a a en pe Ee womanrores 52k xXteh I pe ee i ee ER ER MR ed Se 1 Sr gt 43010000 I SIA 34225000 gt ku me ee Wy a 83008000 Re I ee 0 3 EFRR 8 RD 2 3 KR yk ee J hs a I gt ea i a I J a a 33256012 oe i Le We gt PL ee NEFA pe Fe 43010000 i 42998000 Rn a Mn 44170000 a 44375000 I ee 41419000 i HT ATO TY 43296000 B
37. gt z Ce A FTI UB UB M52XII3 43108000 F327 wt I lo 4 B BJ gt CD19 CD20 HLA DR 43047000 B I B HKappa ww Lambda 43129000 BB y w IH T TU gt CD3 CD5 CD7 43079000 T I T HLA DR E T CD2 ri CD3 CD4 CD8 et fy T 43098000 wy w 1 CD4 T gt yRKCD11b Cp62L NK CD56 GD57 CD16 43062000 NK 1 CD14 CD15 43055000 s I CD45 43052000 w I CD61 84025000 I BrdU 43086000 I Commort Acute Lymphoblastic Leukaemia CALLA CD10 43092000 CALLA w E CD1a 43059000 I Lay 7 LeY 43096000 LeY JU I CD15 43068000 yy I 20 4 IL 1aIL15bIL1RAATL2rIL 6r 21
38. nDNA 2 DNA ds 37724000 U I DNA 1 DNA ss CDNA ENA RNP 1 Sm 34016000 Sm w I 30463000 Sel 70 wy I UmY RF 7 4 I8G 4J YA ieG RFP h KJF7M2 7 Ab UATG TPO TSHL 4 TS Ab TSAb JEyB 2 f gt I PLTAb U gt G JJ 44310000 wk 3 DJY G 43106000 h JPM2 wh 30490000 7f J w 30488000 30317000 F 30489000 84017000 w 43074000 eh 2 3047
39. JU 43349000 7 7 ACP 1 FU 38543000 Ky y v HF gt fvEEA PSTID 43350000 FZ AEE 2 43200000 UJ A2 5 2L gt D7 ACP 38488000 7 7 ff ACP 42864000 7 FT fy by w gt 38544000 js gt RS 33269000 J27 gt J gt 7 h5 gt Pb 44317000 XFITLF E OCT 35 wh re 38545000 j 7 RD 3 2 7 38547000 J w 1 gt PK 44421000 I 6 6 J G 6 PDH 33638000 4 4 7 Y 4 7 Y 4 Es 38539000 II oe
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42. FFGPp EMA mm ooron ee 30628112 U gt y wy JJ JY 3S 30628132 wkh 27 OTC 30167012 30184012 Ck 33819002 os 2 8 J 2 5XI gt 3 23 23xI 1 XxX 25X1 J X 23x1 J X 23xXH gt J X 23XI gt 4 235XI ee gt 1J 23 I J X 23X1 gt J Xx 25XH J 80002002 Eb ee a a wn ee a a I 80020002 5 J I 80024009 25 lt gt 8
43. 3 X2 gt t PTH M gt PTH D Ss 9 fF 30353000 4 2 F w 1 EY PTH 2 2 gt KPTHrPY A kK 30355000 gt K gt NFFR PTHrP 3 gt 30342000 gt gt 3 I XHYJ gt 42862000 w 1 2L gt 44239000 L gt I 2 3 17 FRI17 KS 30369000 j17 FF AFC1I OHCS 17 yf BA 17 NfRD 33238000 1 TR 17 OHCS OP 30320000 EKR ERK gt I FEFAICFTYFOXTFTAY 43159000 EF I FIDHEA S FIAtk yk 7 D gt ALD 31428000 Ry ww I 7 gt ED gt 3 gt 30319000 gt I gt 30440000 J Ss w I jy HVYA 43149000 gt I gt SS xkpzvy 3329
44. 3000 I U 16C Es 16G FU 167 77 43443000 7k wk I 17c FFD Dy 17 ag OHP XHFXFD gt re TULY gt 3 3C F129O AR Pd 3G gt TRC 23 gt 3 gt IA gt 30327002 gt re er 3 FTF 85001000 jyo7F w 43444000 LL ww v gt PRC 43439000 gt 1 mb 43457090 amp ww I HAINYIITFL Sy C AMP 30347000 2Uw2T Lv I 2UwY2AMPIC AMP Sh FF HANP pa EK HANP 7 44443000 hJ 7 FR wh 2 gt BGP 30352000 wy I 24 1 0G 42868000 US 2 5 B CDw75 BB LN1 CD74 28
45. 31 0331010 JIST 14971 JJ gt JIST 14971 J gt 23 2 1 0 17 3 29 121 WA 17 3 31 0331033 V JIST 14971 gt 2 DV Vv 2VWT 17 3 31
46. 5000 3 UE gt UE gt 23U3TR 43075000 gt 43105000 ww 8 I 4 ANCA 30484000 7D 3 e AN CA PR_3 c ANCA MPO ANCA 3 S 30483000 3 IC C1g IG 30498000 H C3d Jo 1 30451000 j Jo 1 I gt gt 2 0 rw 2 30587000 w I i 43128000 GBM 1 S y 84018000 LKM 1 wyk I LKM 84019000 I Dp a
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48. T 43204000 DTU gt abXX ceb 43202000 7U gt LU JU 43347000 75UF w C7 VFALCK MBE 8512002 97 7 yy 4 CKPTITA LCK WMT 38512012 2L7 7 7 1TH Pt gt PP AST 7 m GOT 42901000 5 PS YXFI5 dO 7 2 py LD 7 AY 42907011 ALP ALP 38511000 J 74 FT7 PAY A PEFS3 ALD 38538000 gt MAO 42870000 S gt 3U gt X 3 ChE 38506000 U gt 2 GUA 44171000 wy 7 3v gt PE 43201000 3 7 ES eg TSINITITE sg546000 mf 7SIRTFY th I CTITE 7500 xyr7a AIFI 8300t000 gt 5 7 Py 1 yy FF 30272000 U73v gt I
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