各都道府県知事 殿 厚生労働省医薬食品局長 体外診断用医薬品の認識
Contents
1. 162. 16 169 JIS T
3. 2
4. 16 169 JIS T 14971 17 3 31 0331033 17 3 31
5. 17 3 31 0331010 5 JIS T 14971 17 3 31 0331033
6. 17 3 31 0331010 16 169
7. 16 169 4 16 169 17 3 31 0331033 17 3 31
8. IVD 4 4 17 6 16 0616001 1 17
9. JCTLM Joint Committee on Traceability in Laboratory Medicine NCCLS National Committee for Clinica Laboratory Standards JCCLS Japanese Committee for Clinical Laboratory Standards 3 0 1 mxXn 2 X Y XY 4
10. 17 3 31 0331033 17 3 31 0331010 4 JIS T 14971 pio 17 3 31 0331033
11. 17 3 31 0331033 17 3 31 0331010 8 16 169 9 17 3 31 0331033
12. IVD ul CU 1 23 2 1 17 3 29 121 17 3 31 0331033 IVD 1
13. 17 3 31 0331033 17 3 31 0331010 3 JIS T 14971 17 3 31 0331033
14. LT rm e ER 16 0216004 2 4 TH EL bt 3 14 96 2 23 2 1
15. 1 1 V X 1 X a Xa VE F VIR Ae PIVKA C G C S 8 TM C Y ITDT 2 EPO code 43305000 44416000 44379002 30588000 30589000 44439000 44418000 44419000
16. OTC 30187012 30181012 hCG 33819002 code nnozooz I 27 aooosooz 80008002 aooi1002 I goo14002 I I I 1 I
17. 17 3 31 0331010 3 mn JIST14971 17 3 31 0331033 17 3 31 0331010 17 3 10 0310006 17
18. 8t001000 81002002 30226000 PLY APTT X IL V WE X XLXHD L WEL PIVKA
19. 2 2 43075000 PLTAb 43105000 titraIIR Rukiaha ethikio An PR 3 c ANCA 3 30484000 4 MPO ANCA 30483000 tC C1q IC 30498000 I 3d Jo 1 30461000 Jo 1 I oo 30587000 QB 43128000 GBM 1 84018000 L KM 1
20. m Bo 17 3 10 0310006 17 3 31 0331014 JIS T 14971
21. 2 2 Y 0 WHO JCTLM NCCLS JCCLS
22. 17 3 31 0331010 JTS T 14971 JIST 14971 Rr Or 23 2 1 17 3 29 121 17 3 31
23. 30272000 43349000 1 38543000 PSTD 43350000 A2 PLA 2 43200000 A2 IS 38540000 5 ACP 38498000 ACP 4CP 42864000 GLDH 38544000 IQCDH 33269000 OCT 44317000 amp HBD
24. GCRE 30161002 43103000 HCGi 30332002 HCG LH 2 Ui 8246002 VMA 30453002 HGH GH 30358002 8 2 8 2 m 8 2 B IMG 8 2 82 m B82 MG 30296002 2 ALP 33165002 ca 30187002 Mg 30190002 GTP 98507002 IP 30191
25. PTHrp PTHrP 30355000 30342000 42862000 44239000 17 17 KS 30369000 1 17 47 OHGS 17 17 OHCS 33238000 17 DHEA 30320000 DHEA S 43159000 ALD 31428000 30319000 30440000 HVA 43149000 33293000
26. Dy 6 169 2 16 169 JIS T 14971 17 3 31 0331033 17 3 31 0331010 32 6 10 167 2
27. TAT w 2 2PI 2 PIC PPLPAP 1 PA 1 1 t PA PA 1 X FSF Xa 30575000 43361000 30576000 30567000 30583000 30568000 30578000 30574000 30566000 30579000 43073000 30544000 30551000 30552000 30555000 30554000 43046000 E A F1 2 2
28. 2 SNE 17 3 31 0331033 17 3 31 0331010 17 3 10 0310006 17 3 31 0331014 2 JIS T 14971 MM dha ip 17 3 31 0331033
29. jp 30628062 20 30628072 I B A HCG HGCG 8 HCG LH 30628082 I HPLD P g 30628092 I 1 w 1 GFAP PP EMA EMA A gA GigG M gM Kappa L 30628102 30628112 30628122 30628132
30. sh 2 JIS T 14971 3 5 2
31. 38524000 42931000 42928000 3 42925000 42929000 42920000 30421000 TCA 30451000 30415000 83011000 83012000 1 G 84001000 G s Ig A 30228012 A lgE E jg BE 3027700n E lsE igE tgE
32. BNP 44443000 BGP 30352000 CG 42868000 code BB CDw75 B LN1 CD74 B LN2 E T 30628042 n IT T cel UCHL 1 T 8 T LCAY DR LN3 GH HGH ACT a er FSH 30628052 Pro Y MSH TSH 2 im VP
33. 169 17 3 31 0331033 17 3 31 0331010 16 169 JIS T 14971
34. IL I 1H TI 80017002 80020002 80022001 80024003 80026002 80029002 80032002 80035002 80038002 80041002 H 2 2 I 1 2 2 I RE HI I HN
35. 2 NPN 44178000 44174000 44179000 44176000 jp RPF 44177000 p jp PABA 43199000 jp 2 83007000 30166000 TPESAR 43198000 Ai 30164000 44153000 44154000 43294000 1 5 jgo10000 1 5 EF 1 5AG SIA 34225000 44343000 83008000 30178000 3
36. E lg Bp 90278000 E gE gE 302360g0 Q tgG 84002000 G Ig G 1gA IgM L 84021000 L CH 43254000 CH Cac 30241002 C3c Gc1 Cl 30240000 C1 C3 43815000 C3 84003000 0 30270000 ZZ 1 IAGP 36010000 1 RBP 30252000 Hx 30249000
37. JIS T 14971 17 3 31 0331033 17 3 31 0331010
38. 0331010 32 6 10 167 3 17 3 10 0310006 17 3 31 0331014 JIS T 14971 RE
39. 17 3 31 0331010 JIS T 14971 4 SE 08 17 3 31 0331033 AM i 0 17 3 31 0331010 3 JIS T 14971
40. 0331033 1S T 14971 ON CH 7 3 31 0331033
41. 17 3 31 0331010 JIS T 14971 17 3 31 0331033 17 3 31 0331010 6 0
42. 16w E 16G 43443000 16 ED 30331000 17 17 OHP 30324000 17 30327002 3o Pd 3G 85001Q00 3 PRA 43444000 31410000 PRO 43439000 43457000 Il C AMP 30347000 IT TI AMP C AMP 30260000
43. Common Acute ILymphoblastic Leukaemis 00 D19 43092000 CALLA CD1a 43059000 LeY LeY 43096000 LeY 43068000 43083000 T 2 1 IL1b IL1RA IL2r 30619000 IL6r 43072000 4 30371000 43419000 30373000 rdG F 1 C 30359000 GFBP 1 1 GFBP 1 30361000 1 8 QFBP 3 30362000 3
44. 41755000 30526000 32411000 43094000 43095000 43321000 43097000 42817000 43080000 4306S000 44257000 44308000 38553000 30550000 42899600 30540000 43421000 DL IFDP FDP E E ID FOP D IFDP D D D A FPA Fl 2 ATTE
45. 8 2 3325012 2254 US 44228000 2 3 30179000 33009000 PL 30176012 NEFA 30179000 TC 83010000 44169000 42998000 30156000 8 LP 44378000 44170000 44375000 XX a LP a 41419000 a LPL 44352000 LoAT 43296000
46. 0622004 17 6 22 14 7 14 96 2 35 145 15 12 1 15 534 17 4 1 23 2 1 23 2 4
47. 38545000 38547000 PK 44421000 6 G 6 PDH 33638000 6 38539000 42890000 2 5A PD 44229000 SOoD 43379000 ACB 36542000 IN D NAG 38549000 I 1 33647000 1 3 C 83002000 C
48. I m B0044002 80046002 80048002 80050002 80053002 80055002 2 te RZ Rr T
49. 0331033 17 3 31 0331010 44611000 pH 31369000 jpH 30181002 30167002 33256002 39257002 30157002 31355000 33300000 43117000 33292000 43078000 38502002 sorssopz 43109000 43101002 43085000 43393000
50. 8 4 17 3 10 0310006 17 3 31 0331014 4
51. IAPR 42986000 IAPR H FABP 42860000 1 30264000 1 cTn T TnT T 30268000 30265000 30271000 43224000 P P 44444000 43373000 W IV 7S 44293000 IV 75 3 MMP 3 9 IA SP A 44647000 44211000 3 44441000 2 A D SP D 43194
52. 38512002 IoK CK MM ggi2ni Il AST m GOT 42gotooo D 42907011 ALp ALP Too ALD 36538000 A 42870000 ChE 38506000 GUA 44171000 43201000 36946000 4g47go00 CCAP 8300t000
53. 8 6 AG 5 17 3 31 0331033 0 2 JIS T 14971 a ET
54. 0 9 lt 1 1 3 4 4 1 1 2 TT 50 25
55. 3 31 0331014 17 3 10 0310006 A em 17 3 31 0331014 Td 17 3 31
56. JIS T 14971 23 2 1 17 3 29 121 17 3 31 0331033 17 3 31 0331010 cap 16 169 6 JIS T 14971
57. PRL PRL 30325000 AGTH AGTH 30357000 Al VP 44329000 T3 uptake T3 T3 uptake 30313000 TBG G TBG 30316000 BC 43297000 PTH PTH PTH C PTH C PTH M PTH M 30354000 PTH D PrH D 30353000
58. 43412000 30376000 44254002 82001000 44250000 30559000 9 WW Tr PIVKA II EL C I 8 I C V Li Hr 1 Li 3 1 43264000 TIT 43203000 TT 43204000 E27 49202000 43347000 EK 6K MB
59. LKM 1 1 84oleonn 84023000 IA 84024000 IA 2 A 3 A B B 43108000 84020000 B CD19 a CD20 HLA DR 43047000 B 2 24065 43129000 BB CD3 CD5 CD7 34 43079000 T HLA DR E CD2 T CD3 CD4 CD8 T 43098GO0 T INK CD56 CD57 CD16 43062000 INK CD14 CD15 43085000 CD45 43052000 84025000 BrdU 43086000
60. 0331010 5 16 169 JIS T 14971 El
61. 3 29 121 23 2 1 1 1 2 3 90 2 1 2 3 0 9
62. 8 30258000 B C E 44392000 C 2 44391000 C 42978000 42993000 CETP 3 30384000 B12 30378000 D 1 25 D 30349000 1 25 D3 30157012 43274000 30397000 30400000 IN 30391000 IN 30394000 30449000 30407000 30410000 30418002
63. 000 D KL 6 43462000 K 6 44398000 44155000 4 ANA 30454000 37725000 37765000 LE 84015000 LE AGA 44308000 nDNA 2 DNA ds 37724000 DNAj 1 DNA ss IDNA ENA RNP 44300000 ENA Jo 1 Sm 84016000 Sm RNP 33916000 SS A Ro 43427000 SS A Ro SS B La 42899000 SS La 3
64. 002 30327012 44399000 G IgG 30232002 G A tgA 30228002 A G tgM 30234002 30253002 M 30183002 42849002 30336002 43378002 38541012 30835002 43049000 8 B HCG 8 H0G 30333002 F FSH 30322002 E 30329002 32268002 1
65. 0463000 Scl 70 RP 30500000 5G 0gGr 4gtoooo G RF 2 IgG 44385000 30476000 M2 43106000 M2 Tg IAb ATG 30490000 A NC 30488000 gog17000 ITSH 30489000 TS 84017000 Ab TSAb 43074000 30475000
66. 14971 1 6 17 3 31 0331033 17 3 31 0331010
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