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NIFDC Reference Material

National Institutes for Food and Drug Control is the national statutory institution and the highest technical arbitration institution for the quality inspection of pharmaceutical and biological products. It is the "World Health Organization Drug Quality Assurance Cooperation Center" designated by the World Health Organization. NIFDC is responsible for the implementation of the approval and registration inspection, import inspection, supervision inspection, safety evaluation, and batch issuance of biological products for products in multiple fields such as drugs, biological products, medical devices, food, health food, cosmetics, laboratory animals, and packaging materials. NIFDC is responsible for the research, distribution and management of national drug and medical device reference materials and bacterial strains used in production verification, and carry out related technical research work.

Item Cat No. Chinese Name Englis Name Size
1 150519 胰岛素国家标准品 Insulin National Standard 55 mIU
2 150530 促甲状腺素（TSH）免疫测定用国家标准品 National Standard for Thyroid Stimulating Hormone (TSH) Immunoassay 3.12mIU
3 150531 促黄体生成素（LH）免疫测定用国家标准品 National standard for luteinizing hormone (LH) immunoassay 1.12 IU，0.5ml
4 150533 促卵泡生成激素(FSH) 免疫测定用国家标准品 National Standard for Follicle Stimulating Hormone (FSH) Immunoassay 0.5ml
5 150534 人生长激素免疫测定用国家标准品 National standard for human growth hormone immunoassay 2.3mIU
6 150535 人绒毛膜促性腺激素β  亚单位（hCG-β）免疫测定用国家标准品 National standard for immunoassay of human chorionic gonadotropin β subunit (hCG-β) 240ng/0.5mL
7 150536 人胎盘泌乳素（HPL）免疫测定用国家标准品 National standard for human placental prolactin (HPL) immunoassay 14.2μg
8 150540 铁蛋白(Fer)国家标准品 Ferritin (Fer) National Standard 790ng
9 150542 甲胎蛋白（AFP）免疫测定用国家标准品 National standard for immunoassay of alpha-fetoprotein (AFP) 支
10 150543 前列腺特异性抗原（PSA）免疫测定用国家标准品 National standards for prostate specific antigen (PSA) immunoassay 95ng；
11 150544 游离前列腺特异性抗原（f-PSA）免疫测定用国家标准品 National standard for immunoassay of free prostate specific antigen (f-PSA) 170ng
12 150550 三碘甲腺原氨酸（T3）免疫测定用国家标准品 National standard for immunoassay of triiodothyronine (T3) 50ng
13 150551 甲状腺素（T4）免疫测定用国家标准品 National Standard for Thyroxine (T4) Immunoassay 940ng
14 150552 反三碘甲腺原氨酸（rT3）免疫测定用国家标准品 National standard for anti-triiodothyronine (rT3) immunoassay 860ng
15 150553 C-肽国家标准品 C-peptide national standard 77ng
16 150554 胰高血糖素（Glucagon）免疫测定用国家标准品 National Standards for Glucagon Immunoassay 19μIU/19ng
17 150555 人绒毛膜促性腺激素（HCG）免疫测定用国家标准品 National standard for human chorionic gonadotropin (HCG) immunoassay 8.28IU，0.5ml
18 150556 抗甲状腺球蛋白抗体（Anti-TgAb）国家标准品 National Standard for Anti-TgAb 支
19 150557 抗甲状腺过氧化物酶抗体（Anti-TpoAb）国家标准品 Anti-thyroid peroxidase antibody (Anti-TpoAb) national standard 支
20 210015 淋病PCR试剂盒质控参考品 Quality control reference material for gonorrhea PCR kit 26 支/套
21 220009 HIV抗体国家参考品 HIV antibody national reference 0.5ml
22 220013 HIV抗体胶体金类诊断试剂用国家参考品 National reference material for HIV antibody colloidal gold diagnostic reagents 0
23 220014 人类免疫缺陷病毒（HIV）核酸血筛国家参考品 National Reference Material for Human Immunodeficiency Virus (HIV) Nucleic Acid Blood Screening 0.5ml/只
24 220015 HIV-1   P24抗原国家参考品 HIV-1 P24 antigen national reference material 0.5ml/ml
25 220016 HIV抗体确证试剂国家参考品 National Reference Material for HIV Antibody Confirmation Reagent 0.5ml，共27 支
26 220017 HIV-1RNA国家参考品 HIV-1RNA National Reference Material 0.5mL
27 220018 HIV-1耐药性分析试剂国家参考品 National Reference Material for HIV-1 Drug Resistance Analysis Reagent 48 支/套
28 220019 人类免疫缺陷病毒口腔黏膜渗出液抗体国家参考品 National Reference Material for Human Immunodeficiency Virus Oral Mucosal Exudate Antibody  
29 220020 HIV抗体尿液快速检测试剂国家参考品 HIV antibody urine rapid test reagent national reference 46 支/套
30 220021 人类免疫缺陷病毒1型（HIV-1）RNA标准品 Human Immunodeficiency Virus Type 1 (HIV-1) RNA Standard 1mL
31 230019 血吸虫病IgG抗体检测试剂用国家参考品 National reference material for schistosomiasis IgG antibody detection reagent 0.5ml，32支/套
32 230023 弓形虫IgG诊断试剂检测国家参考品 National reference material for the detection of Toxoplasma IgG diagnostic reagent 0.5ml，24支/套
33 230029 包虫病IgG抗体国家参考品 National Reference Material for Hydatid IgG Antibody 0.5ml
34 230030 结核分支杆菌PCR检测试剂盒用国家参考品 National Reference Material for Mycobacterium Tuberculosis PCR Detection Kit 44 支/套，1mL
35 230033 结核分支杆菌利福平耐药基因检测试剂用国家参考品 National reference material for rifampicin resistance gene detection reagent of Mycobacterium tuberculosis 31 支
36 230034 结核分枝杆菌异烟肼耐药基因检测试剂用国家参考品 National Reference Material for Isoniazid Resistance Gene Detection Reagent for Mycobacterium Tuberculosis 30 支
37 230037 恶性疟原虫抗原检测试剂盒用全血国家参考品 Whole blood national reference material for Plasmodium falciparum antigen detection kit 0.1ml，20支/套
38 230038 间日疟原虫抗原检测试剂盒用全血国家参考品 Whole blood national reference material for Plasmodium vivax antigen detection kit 0.1ml
39 240013 梅毒诊断试剂国家参考品（特异性） National Reference Material for Syphilis Diagnostic Reagents (Specificity) 34 支；1000μl
40 250016 发热伴血小板减少综合征布尼亚病毒（SFTSV）核酸检测试剂国家参考品 Fever with thrombocytopenia syndrome Bunya virus (SFTSV) nucleic acid detection reagent national reference material  
41 280020 抗A抗B血型定型试剂效价测定用国家参考品 National reference for determination of potency of anti-A and anti-B blood grouping reagents 1.0mL
42 290001 华枝睾虫病IgG抗体冻干血清国家参考品 National Reference Material of Lyophilized Serum for Clonorchiasis IgG Antibody 0.2ml，21支/套
43 300003 乙型肝炎病毒表面抗原（HBsAg）国家参考品 Hepatitis B virus surface antigen (HBsAg) national reference material 0.5mL
44 300004 乙型肝炎病毒表面抗体（HBsAb）国家标准品（定性检测） Hepatitis B virus surface antibody (HBsAb) national standard (qualitative test) 0.5ml/1.0ml
45 300005 乙型肝炎病毒e抗原（HBeAg）国家参考品 Hepatitis B virus e antigen (HBeAg) national reference material 27 支/套
46 300006 乙型肝炎病毒e抗体（HBeAb）国家参考品 Hepatitis B virus e antibody (HBeAb) national reference material 0.5ml
47 300007 乙型肝炎病毒核心抗体(Anti-HBcAb)国家参考品 Hepatitis B virus core antibody (Anti-HBcAb) national reference material 32 支/套
48 300009 乙型肝炎病毒DNA国家参考品 National Reference Material of Hepatitis B Virus DNA 0.5ml
49 300010 丙型肝炎病毒抗体国家参考品 National Reference Material for Hepatitis C Virus Antibody 65 支/套
50 300011 戊型肝炎病毒IgM抗体国家参考品 Hepatitis E virus IgM antibody national reference material 0.5ml
51 300012 丙型肝炎病毒RNA国家参考品 Hepatitis C virus RNA national reference material 21 支/套
52 300013 丙型肝炎病毒抗体快速检测试剂国家参考品 National Reference Material of Hepatitis C Virus Antibody Rapid Detection Reagent 支
53 300014 戊型肝炎病毒IgG抗体国家参考品 National Reference Material for Hepatitis E Virus IgG Antibody 42 支/套
54 300015 乙型肝炎病毒表面抗体（HBsAb）国家参考品（定量检测） Hepatitis B virus surface antibody (HBsAb) national reference material (quantitative test) 0.5ml
55 300022 乙型肝炎病毒核酸定量国家标准品 Hepatitis B virus nucleic acid quantitative national standard 0.5ml
56 300023 丙型肝炎病毒核心抗原检测试剂国家参考品 National Reference Material for Hepatitis C Virus Core Antigen Detection Reagent 0.5ml
57 340001 乙型肝炎病毒e抗原快速诊断试剂国家参考品 National Reference Material of Hepatitis B Virus e Antigen Rapid Diagnosis Reagent 27 支/套
58 340002 乙型肝炎病毒e抗体快速诊断试剂国家参考品 Hepatitis B virus e antibody rapid diagnostic reagent national reference material 27 支/套
59 340003 乙型肝炎病毒核心抗体快速诊断试剂国家参考品 National Reference Material of Hepatitis B Virus Core Antibody Rapid Diagnostic Reagent 32 支/套
60 340004 乙型肝炎病毒表面抗原快速诊断试剂国家参考品 National Reference Material for Rapid Diagnosis of Hepatitis B Virus Surface Antigen 27 支/套
61 340005 乙型肝炎病毒表面抗体快速诊断试剂国家参考品 National Reference Material for Rapid Diagnosis of Hepatitis B Virus Surface Antibody 22 支/套
62 340006 *乙型肝炎病毒核酸基因分型（B型）国家标准品 *National standard for hepatitis B virus nucleic acid genotyping (type B)  
63 340007 *乙型肝炎病毒核酸基因分型（C型）国家标准品 *National Standard for Hepatitis B Virus Nucleic Acid Genotyping (Type C)  
64 340008 *乙型肝炎病毒RNA检测试剂国家标准品 *National standard of hepatitis B virus RNA detection reagent  
65 340016 丙型肝炎病毒RNA（1b型）国家标准品 Hepatitis C virus RNA (type 1b) national standard 0.5ml
66 340017 丙型肝炎病毒基因分型（1b型）国家标准品 National standard for hepatitis C virus genotyping (type 1b) 0.5ml
67 340018 丙型肝炎病毒基因分型（2a型）国家标准品 National Standard for Hepatitis C Virus Genotyping (Type 2a) 0.5ml
68 340019 轮状病毒抗原检测试剂用国家参考品 National reference materials for rotavirus antigen detection reagents 0.5ml,1ml
69 340020 甲型肝炎病毒核酸检测试剂用国家标准品 National standard for hepatitis A virus nucleic acid detection reagent 0.5ml
70 340021 乙型肝炎病毒表面抗原国家标准品 National Standard of Hepatitis B Virus Surface Antigen 0.5ml
71 340022 乙型肝炎病毒e抗原国家标准品 National standard for hepatitis B virus e antigen 0.5ml
72 340024 柯萨奇病毒A16型核酸检测试剂国家参考品 Coxsackie virus A16 nucleic acid detection reagent national reference 0.5ml
73 340025 乙型肝炎病毒核心IgM抗体国家参考品 National Reference Material for Hepatitis B Virus Core IgM Antibody 22 支/套
74 340026 丙型肝炎病毒基因分型（6a型）国家标准品 National Standard for Hepatitis C Virus Genotyping (Type 6a) 0.5ml
75 340027 丙型肝炎病毒基因分型（3a型）国家标准品 National Standard for Hepatitis C Virus Genotyping (Type 3a) 0.5mL
76 340028 *丙型肝炎病毒基因分型（4型）国家标准品 *National standard for hepatitis C virus genotyping (type 4)  
77 340029 *丙型肝炎病毒基因分型（5型）国家标准品 *National standard for hepatitis C virus genotyping (type 5)  
78 340030 甲型肝炎病毒IgM抗体国家参考品 National Reference Material for Hepatitis A Virus IgM Antibody 0.3ml
79 340031 甲型肝炎病毒IgG抗体国家参考品 National Reference Material for Hepatitis A Virus IgG Antibody 0.3ml
80 340033 乙型肝炎病毒pre-s1抗原国家参考品 National Reference Material for Hepatitis B Virus Pre-s1 Antigen 17 支/套
81 340034 乙型肝炎病毒pre-s2抗原国家参考品 National Reference Material for Hepatitis B Virus Pre-s2 Antigen 0.5ml，17支/套
82 340035 乙型肝炎病毒e抗体国家标准品 National standard for hepatitis B virus e antibody 0.5ml
83 340036 乙型肝炎病毒核心抗体国家标准品 National standard of hepatitis B virus core antibody 0.5ml
84 360002 人乳头瘤病毒 L1 基因分型参考品 Human papillomavirus L1 genotyping reference 0
85 360004 巨细胞病毒IgG抗体国家参考品 National Reference Material for Cytomegalovirus IgG Antibody 21 支；500ul
86 360005 风疹病毒IgG抗体国家参考品 National Reference Material for Rubella Virus IgG Antibody 16 支；500ul，
87 360006 风疹病毒IgM抗体国家参考品 National Reference Material for Rubella Virus IgM Antibody 22 支；500ul，
88 360007 测序仪性能评价用脱氧核糖核酸国家参考品 Deoxyribonucleic acid national reference material for sequencer performance evaluation 12 支/套
89 360008 高通量测序用外周血胎儿染色体非整倍体（T21、T18和T13）国家参考品 National reference material for fetal chromosomal aneuploidy (T21, T18 and T13) in peripheral blood for high-throughput sequencing 227 支/套
90 360010 胚胎植入前染色体非整倍体国家参考品 National reference material for preimplantation chromosomal aneuploidy 89 支/套，2.5μl
91 360011 胰岛素样生长因子-1（IGF-1）国家标准品 Insulin-like growth factor-1 (IGF-1) national standard 0.5ml
92 360012 尿素，尿酸总蛋白国家标准品 Urea, the national standard of total uric acid protein 0.5ml
93 360013 耳聋基因突变检测国家参考品 National Reference Material for Deafness Gene Mutation Detection 23 支/套
94 360014 地中海贫血核酸检测国家参考品 National Reference Material for Thalassemia Nucleic Acid Detection 32 份/套
95 360016 BRCA基因突变检测国家参考品 National Reference Material for BRCA Gene Mutation Detection 20ul，25支/套
96 360017 抗D（IgM）血型定型试剂效价测定用国家参考品 National reference material for determination of anti-D (IgM) blood typing reagent potency 1mL
97 360018 锂、钠、钾、镁、钙、氯复合电解质冰冻人血清国家标准品 Lithium, sodium, potassium, magnesium, calcium, chlorine compound electrolyte frozen human serum national standard 0.5ml，3支/套
98 360019 户尘螨过敏原特异性IgE抗体血清国家参考品 House dust mite allergen-specific IgE antibody serum national reference material 0.5mL
99 360020 艾蒿花粉过敏原特异性IgE抗体血清国家参考品 Mugwort pollen allergen-specific IgE antibody serum national reference material 0.5mL
100 360021 抗C（IgM）血型定型试剂效价测定用国家参考品 National reference material for determination of anti-C (IgM) blood typing reagent potency 1.0mL
101 360022 冻干型人T/B/NK淋巴细胞国家参考品（流式细胞法） Freeze-dried human T/B/NK lymphocyte national reference material (flow cytometry) 1ml
102 360023 脆性X综合征FMR1基因核酸检测国家参考品 Fragile X syndrome FMR1 gene nucleic acid test national reference material 21 份/套
103 360024 染色体拷贝数变异检测国家参考品 National Reference Material for Chromosome Copy Number Variation Detection 43 支/套
104 360025 基于SNP检测方法的胎儿染色体非整倍体（21三体、18三体和13三体）国家参考品 National reference material for fetal chromosomal aneuploidy (trisomy 21, trisomy 18 and trisomy 13) based on SNP detection method 104 支/套
105 360027 胚胎植入前地中海贫血诊断国家参考品 National Reference Material for Preimplantation Thalassemia Diagnosis 20 支/套
106 360028 微卫星不稳定性（MSI）检测国家参考品 National Reference Material for Microsatellite Instability (MSI) Testing 62 支/套
107 360029 新生儿筛查氨基酸和肉碱干血片国家标准品 National Standards for Amino Acid and Carnitine Dry Blood Tablets for Newborn Screening 5 套/袋
108 360030 葡萄糖-6-磷酸脱氢酶（G6PD）基因突变检测国家参考品 Glucose-6-phosphate dehydrogenase (G6PD) gene mutation detection national reference material 30 支/套
109 360033 总胆红素冰冻人血清国家标准品 Total Bilirubin Frozen Human Serum National Standard 0.5ml
110 360034 睾酮冰冻人血清国家标准品 National Standard of Testosterone Frozen Human Serum 0.5ml
111 360035 人类白细胞抗原B27核酸检测国家参考品 National Reference Material for Human Leukocyte Antigen B27 Nucleic Acid Detection 0
112 360036 人类白细胞抗原B5801/5701/1502核酸检测国家参考品 Human leukocyte antigen B5801/5701/1502 nucleic acid detection national reference material 0
113 360037 血浆ctDNA   KRAS/NRAS/EGFR/ BRAF/MET基因突变检测国家参考品 Plasma ctDNA KRAS/NRAS/EGFR/BRAF/MET gene mutation detection national reference material 4.2mL
114 360038 长读长测序平台结构变异检测单体型国家参考品 Long-read sequencing platform structural variation detection haplotype national reference  
115 360040 第二代EGFR/MET/ALK基因突变检测国家参考品 The second-generation EGFR/MET/ALK gene mutation detection national reference product 93 支/套
116 360041 第二代KRAS/NRAS/BRAF/PI3KCA基因突变检测国家参考品 The second-generation KRAS/NRAS/BRAF/PI3KCA gene mutation detection national reference product 55 支/套
117 360042 肿瘤突变负荷检测国家参考品 National Reference Material for Tumor Mutation Burden Testing 60 支/套
118 370002 EB病毒衣壳抗原IgA抗体国家参考品 EB virus capsid antigen IgA antibody national reference 26 支/套
119 370003 甲型流感病毒抗原检测试剂国家参考品 National Reference Material for Influenza A Virus Antigen Detection Reagent 0.5ml，24支
120 370004 乙型流感病毒抗原检测试剂国家参考品 National Reference Material for Influenza B Virus Antigen Detection Reagent 0.5ml，23支
121 370005 人细小病毒B19核酸检测试剂国家参考品 National Reference Material of Human Parvovirus B19 Nucleic Acid Detection Reagent 1mL，26支
122 370007 第二代甲/乙型流感病毒核酸检测试剂国家参考品 The second generation influenza A/B virus nucleic acid detection reagent national reference product 0
123 370009 人细小病毒B19IgG抗体检测试剂国家参考品 National Reference Material for Human Parvovirus B19IgG Antibody Detection Reagent  
124 370010 扎伊尔型埃博拉病毒核酸检测试剂国家参考品 National Reference Material for Zaire Ebola Virus Nucleic Acid Detection Reagent  
125 370013 甲/乙型流感病毒抗原检测试剂国家参考品 National Reference Material for Influenza A/B Antigen Detection Reagent 0.5ml,23支/套
126 370015 单纯疱疹病毒1型IgG抗体检测试剂国家参考品 National Reference Material for Herpes Simplex Virus Type 1 IgG Antibody Detection Reagent  
127 370016 单纯疱疹病毒2型IgG抗体检测试剂国家参考品 National Reference Material for Herpes Simplex Virus Type 2 IgG Antibody Detection Reagent 18 支；500ul，1
128 370017 肠道病毒EV71型核酸检测试剂国家参考品 Enterovirus EV71 nucleic acid detection reagent national reference material 0.5ml
129 370018 水痘带状疱疹病毒IgG抗体检测试剂国家参考品 National Reference Material for Varicella-Zoster Virus IgG Antibody Detection Reagent  
130 370019 寨卡病毒核酸检测试剂国家参考品 National Reference Material of Zika Virus Nucleic Acid Detection Reagent 0
131 370020 季节性流感病毒H3亚型核酸检测试剂国家参考品 National Reference Material of Seasonal Influenza Virus H3 Subtype Nucleic Acid Detection Reagent 0
132 370021 肺炎衣原体IgG抗体检测试剂国家参考品 National Reference Material for Chlamydia Pneumoniae IgG Antibody Detection Reagent 10 支
133 370022 ABO反定型血型类诊断试剂特异性项目用国家参考品 National reference material for ABO anti-typing blood group diagnostic reagent specific project 0.5mL，4支
134 370023 人细小病毒B19核酸检测试剂国家标准品 National standard of human parvovirus B19 nucleic acid detection reagent 1mL，8支
135 370026 34种细菌和真菌感染多重核酸检测试剂国家参考品 34 national reference materials for multiple nucleic acid detection reagents for bacterial and fungal infections 0.2ml
136 370027 抗人球蛋白试剂（抗C3d）国家参考品 Anti-human globulin reagent (anti-C3d) national reference 400μL，1支
137 370028 抗人球蛋白试剂（抗IgG）国家参考品 Anti-human globulin reagent (anti-IgG) national reference 500μL，1支
138 370029 抗人球蛋白试剂（抗IgG+C3d）国家参考品 Anti-human globulin reagent (anti-IgG+C3d) national reference 500μL，1支
139 370030 *B族链球菌核酸检测试剂国家参考品 *National reference material for nucleic acid detection reagents of group B streptococcus  
140 370033 登革病毒核酸检测试剂国家参考品 National Reference Material for Dengue Virus Nucleic Acid Detection Reagent 12 支，0.5ml
141 370034 单纯疱疹病毒1+2型IgG抗体检测试剂国家参考品 National Reference Material for Herpes Simplex Virus Type 1+2 IgG Antibody Detection Reagent 18 支；500ul，
142 370035 梅毒螺旋体抗体快速试剂国家参考品 Treponema pallidum antibody rapid reagent national reference material 33 支；1000μl
143 370036 梅毒螺旋体抗体国家参考品（化学发光法） Treponema pallidum antibody national reference product (chemiluminescence method) 34 支；1000μl
144 370037 中东呼吸综合征冠状病毒核酸检测试剂国家参考品 National Reference Material for Middle East Respiratory Syndrome Coronavirus Nucleic Acid Detection Reagent  
145 370038 *艰难梭菌及其毒素A和B基因核酸检测试剂国家参考品 *Clostridium difficile and its toxin A and B gene nucleic acid detection reagent national reference material  
146 370040 *EB病毒核酸检测试剂国家标准品 *National standard of EB virus nucleic acid detection reagent  
147 370041 梅毒非特异性抗体诊断试剂国家参考品 National Reference Materials for Syphilis Non-specific Antibody Diagnostic Reagents 50 支/套，200μl
148 370042 马尔堡病毒核酸检测试剂国家参考品 National Reference Material of Marburg Virus Nucleic Acid Detection Reagent  
149 370043 结核抗体检测试剂（酶联免疫法）国家参考品 Tuberculosis antibody detection reagent (enzyme-linked immunoassay) national reference material 400ul
150 370044 结核抗原检测试剂国家参考品 National Reference Materials for Tuberculosis Antigen Detection Reagents  
151 370045 人类免疫缺陷病毒抗体国家参考品 National Reference Material for Human Immunodeficiency Virus Antibody 48 支；2000μl
152 370046 第二代人脲原体核酸检测国家参考品 National Reference Material for Second Generation Human Ureaplasma Nucleic Acid Detection 0
153 370048 梅毒螺旋体抗体国家参考品（凝集法） Treponema pallidum antibody national reference material (agglutination method)  
154 370050 第二代人感染H7N9禽流感病毒核酸检测试剂国家参考品 The second generation human infection H7N9 avian influenza virus nucleic acid detection reagent national reference material 2.5mL，1支
155 370051 第二代甲型流感病毒核酸检测试剂国家参考品 National Reference Material of Second Generation Influenza A Virus Nucleic Acid Detection Reagent 0
156 370052 第二代乙型流感病毒核酸检测试剂国家参考品 National Reference Material of Second Generation Influenza B Virus Nucleic Acid Detection Reagent 0
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167 370099 新型冠状病毒核酸检测试剂国家参考品 National Reference Materials for Novel Coronavirus Nucleic Acid Detection Reagents