薬食発第0622006号 - 医療機器基準等情報提供ホームページ
Contents
1.2. 16 169 JIS T 14971
3. ii 16 169
4. JIS T 14971 0 0 Rio 17 3 10 0310006 SM 0331014 JIS T 14971
5. 2 2 2
6. IVD 4 4 17 6 16 0616001 1
7. 17 3 31 0331014 Na 0216004 Pe 17 2 16 0216005 11 PT 30539000 2 GLU 30221003 D 44342000 ID 3 8 44562003 3
8. Ne 16 169 16 169 UE 0 0216004 Me 17 2 16 0216005 16 169
9. 9 0 0216004 1 17 2 16 0216005 JIS T 14971 JIS T 14971 17 6 22 0622006 17 2 16 0216004
10. 16 169 JIS T 14971 17 6 22 0622006 17 2 16
11. Y 0 WHO CTLM NCCLS JCCLS JCTLM Joint Committee on Traceab
12. JIS T 14971 17 2 16 0216004 ht i 17 2 16 0216005 JIS T 14971 3 0 i a 17 2 16 0216004 17 2 16 0216005
13. 3 ii S UN Ne 4 5
14. 1 1 2 100 50
15. i DA NONE Pe 17 2 16 0216004 i IE 17 2 16 0216005 5 JIS T 14971 DA 17 2 16 J 0216004 TE 0 17 2 16 0216005
16. 17 2 16 0216004 17 2 16 0216005 JIS T 14971 17 2 16 0216004 17 2 16 0216005
17. 80047003 80049003 ES 80052003 80054003 mm 2 HIV HCV HDV HTLV 22
18. 17 2 16 0216004 17 2 16 0216005 17 3 10 0310006 Bo 17 3 31 0331014 9 JIS T 14971 Os SR 0 0 _ MS i SC 1 BA 0216004 10 AN CO 17 2 16 0216005 3
19. JIS T 14971 17 2 16 0216004 1 ee 17 2 16 0216005 JIS T 14971 i WS
20. 9 17 2 16 0216004 Me 17 2 16 0216005 2
21. 32504000 ll 43353000 A 43175000 A 8 MRSA TSST 1 TSST 37758000 43193000 44450000 1 44449000 19 B HBc B HBs B HBs HPV 30628003
22. 1 HSV 1 HSV 1 TH HSV D HSV 2 30628013 w 1 AAOT AFP ER CEA PSA 30628023 PSAP PSAP PAP NSE ErbB 2 HER2 neu HER2 NEU 30628033 20 3 go004003 80007003 Na
23. 17 2 16 0216004 17 2 16 0216005 16 169 OS TIS T 14971 17 2 16 0216004 17 2 16 0216005 16 169
24. IVD CS Ci 1 17 2 16 0216004 IVD 1 CR IVD 3 14 96 2 14 1 19 2 1
25. 0 43162000 rie 44408003 44408013 30654000 Mn 30710000 HH A T B 17 i b geo04000 b 5 i a 0 8 O 30718000 E 37752000 mI 0 32508000 0 ll 30705000 mI 32506000 a E 42957000
26. 17 2 16 0216004 17 2 16 0216005 3 JIS T 14971 CE 2 0 17 2 16 0216004 Na CC 17 2 16 0216005 4 JIS T 14971
27. TP 30687000 ft TPigM 44429000 M mf do 32450000 Tm A 90252 30697000 30704000 i A 30714000 D 1 Weil Felix 30717000 43250000 44428000 il CF 7746000 37748000
28. NR JIS T 14971 A CO i 0216004 CO SS 17 2 16 0216005 i Ne 2 ISA JIS T 14971
29. o a Mg 17 2 16 0216005 32 6 10 167 16 169 2 JIS T 14971 A NN 0216004 i 17 2 16 0216005
30. VCA IgG EB EBNA igG 84006000 G EB igA EB V CA IgA EB VCA IgA EB EBNA lgA EB lgM EB EBNA IgM EB VCA jgM EB V CA lgM 84007000 EE 33902000 M 37731000 A B A 7 37729000 37728000
31. 37741000 Ril 30816000 igM 30818000 M 2 igG 30817000 G 0 0 NE 30700000 TE a 84022000 I i a 42846000 mI 0157LPS 44025000 0157LPS It a on 1 3 B A B E Coli k1 C b 7 B 44198000 gg EN C W135 A Y
32. 0216004 17 2 16 0216005 2 16 169 3 2 0600 JIST14971 A 1 3 4 17
33. 0622006 17 6 22 14 7 14 96 2 35 145 15 12 15 534 17 4 1 14 1 19 2 1 A 0 RE
34. HTI V HCV H DV HTLV 1 1 2 3 90 2 1 2 3 0 9 0 9 1 1 3 4 4
35. 2 41759003 1 41759013 G G 44016000 M M 44027000 12 3 30797000 E 30799000 AMG 20go0000 G lgM M EB EB EBNA 30809000 EB IgG EB EA lgG EB V CA IgG EB
36. 44321000 30794000 lgG 30796000 A A BB RS RS RS 30813000 A B 43228000 32487000 13 3 jgG jgM jgG IgM 37732000 30815000 SV5 42994000 SV41 SV41 43955000 90
37. es HBe 30737000 1B e 4 a a ES SR EAS EA LL HBs 30723000 1B HT HBs 30725000 B pre S2 44200000 B pre S2 a 4 HBs 44199000 AGE 40 41 41274000 E CF jgG naosooo G IgM 3ogoeooo M 30804000 TE a ta nn bb a nA a 1 1 30802003 1 ii 2 30802013
38. LH 30515003 3 14800 43148003 4 ooo HCG 6 MRSA 44456000 ES 33361000 MI MRSA 8 30656003 MRSA 44376000 MRSA i
39. 2B 44029000 5 30713000 G lgG A 44202000 A 0 2 PGL HRP 2 30702000 44020000 44201000 84005000 HRP 2 30692000 11 3 A HAV 30720000 A TE lgG HAV jgM HAV 30722000 A M PR 22 PRE 1 HBc 30731000 B lgM HBc 30733000 74455 2RSM220 HBe 30734000
40. GAT i 1 SP1 44325000 1 PIVKA HH 44379003 IPIVKA IT AR 19 go287000 19 mE 5 sate I 43237000 a ll a _ 6 43270000 IErbB 2 Le CSLEX 42825000 Le li 1 C PiCP 42822000 1 C ul 1 C C ES ICTP 42941000 1 C 1 N NT 43299000 1 N E R ER PR DPD LCAP Lung cancer lassociated protein T K TK SS
41. goo10003 goo13003 mE a0016003 iR 80021003 mT 80023003 go025003 go028003 0 80034003 mf TR go037003 E 21 gt S00 Do EN 80043003 3 lt gt 80045003
42. 1 30510000 BTA 30293000 30294000 38217000 44432000 30348000 44430000 LCAP 44254013 84027000 S 2 CF lgG gt 7 RN IgG 30680000 G HI IgA A gt IgA 30679000 A i IgM jgM 30681000 M Nu O AS0 377seooo O 2 ASK 9o493000 m 440240
43. 3 29 1 84026000 CEA 30288000 AFP 30295000 HE AFP 43480000 AFP L3 BFP BFP 44440000 E CA125 CA125 CA125 30283000 125 HE 125 CA125 CA602 43034000 602 ff re 43150000 130 I CA15 3 CA15 3 30279000 15 3 CA15 3 BCA225 43825000 BCA225 mT CA19 9 CA19 9 CA 30280000 19 9 19 9 CA
44. 32 6 10 167 fF 3 17 3 10 0310006 17 3 31 0331014 JIS T 14971 A
45. 3 10 0310006 17 3 31 0331014 16 169 1 16 169 JIS T 14971 17 2 16 0216004
46. 00 m DNase B 30491000 DNase B 30492000 TE 8 A A 44031000 IA E A 30682000 il 42947000 Widal 44028000 6 1 37723000 I sd 44021000 30689000 HIE EA 44204000 2 lt igG 0691000 30716000
47. 19 9 50 CA50 30281000 50 CA72 4 CA72 4 30282000 72 4 Tn STN 43306000 Tn 1 KMO1 43309000 KMO1 EE Re a AA 30291000 SCC hl Sm 43428000 HE TPA 30292000 HI TPA IAP 36010010 002 34226000 37286000 EE Tr 37287000 w oy 1 0 bs 3145000 NSE 30301000 2 43195000
48. 8009 38877003 38877013 B191gG B19IgM jj 38877023 SV5 SV5 SV41 B1 9 G B1 9 M 1 4 4 ABO Rh D E e C c Rh Hr IDNA HLA DR 30597000 30598000 43111000 43113000 30608000 30612000 ABO Rh II 5 LH
49. JIS T 14971 i 25 1 0216004 DS 17 2 16 0216005 sa 17 3 10 0310006 17 3 31 0331014 17 3 10 0310006 UA E
50. ility in Laboratory Medicine NCCLS National Committee for Clinical Laboratory Standards JCCLS Japanese Committee for Clinical Laboratory Standards 3 1 mxn 2 X Y Y ara 4
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