Anti-Cyclic Citrullinated Peptide Antibody Assay Kit (Latex Enhanced Immune Turbidimetric Method) - NMPA Registration 皖械注准20242400116
Access comprehensive regulatory information for Anti-Cyclic Citrullinated Peptide Antibody Assay Kit (Latex Enhanced Immune Turbidimetric Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 皖械注准20242400116 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on August 06, 2024.
This page provides complete registration details including registrant information, province location (Anhui), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
This product is used for in vitro quantitative determination of anti-cyclic citrullinated peptide antibody (Anti-CCP) content in human serum or plasma samples.
该产品用于体外定量测定人血清或血浆样本中抗环瓜氨酸肽抗体（Anti-CCP）的含量。
Composition of the main components concentration R1 Tris buffer Polyethylene glycol-20000 100mmol/L 5g/L R2 latex granule-coated cyclic citrullinated peptides Glycine buffer to taste 50mmol/L Calibrator (optional) Cyclic citrullinated peptide antibody Target concentration: 400 U/mL Control Levels 1 & 2 (Optional) Cyclic Citrullinated Peptide Antibody Level 1 Target Concentration: 125 U/mL Level 2 target concentration: 250 U/mL Note: 1. The components in different batch number kits are not interchangeable; 2. The calibrators and quality controls are batch-specific, please refer to the target value list for details; 3. The product calibrator can be traced back to the enterprise work calibrator.
组成 主要成分 浓度 R1 Tris 缓冲液 聚乙二醇-20000 100mmol/L 5g/L R2 胶乳颗粒包被的环瓜氨酸肽 甘氨酸缓冲液 适量 50mmol/L 校准品（选配） 环瓜氨酸肽抗体 目标浓度：400U/mL 质控品水平一、二 （选配） 环瓜氨酸肽抗体 水平一目标浓度：125U/mL 水平二目标浓度：250U/mL 注：1.不同批号试剂盒中各组分不可互换； 2.校准品、质控品具有批特异性，详情请见靶值单； 3.产品校准品溯源至企业工作校准品。
1. Unopened reagents, calibrators, and quality controls should be stored at 2°C~8°C in the dark, with a validity period of 12 months, and freezing is prohibited; 2. After opening the bottle, the reagent should be stored at 2°C ~ 8°C in the dark, and the validity period is 28 days; 3. The reconstituted calibrator should be stored at 2°C ~ 8°C in the dark, pay attention to volatilization, and be valid for 7 days; 4. The reconstituted quality control should be stored at 2°C ~ 8°C in the dark, pay attention to volatilization, and be valid for 7 days. 1. Unopened reagents, calibrators, and quality controls should be stored at 2°C~8°C in the dark, with a validity period of 12 months, and freezing is prohibited; 2. After opening the bottle, the reagent should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 28 days; 3. The reconstituted calibrator is stored at 2°C ~ 8°C in the dark, pay attention to volatilization, and the validity period is 7 days; 4. The reconstituted quality control is stored at 2 °C ~ 8 °C in the dark, pay attention to volatilization, and the expiration date is 7 days.
1.未开封的试剂、校准品、质控品在 2℃~8℃避光保存，有效期12个月，禁止冷冻； 2.开瓶后试剂在 2℃ ~ 8℃避光保存，有效期28 天； 3.复溶后的校准品 2℃ ~ 8℃避光保存，注意挥发，有效期7 天； 4.复溶后的质控品 2℃ ~ 8℃避光保存，注意挥发，有效期7 天。1.未开封的试剂、校准品、质控品在2℃~8℃避光保存，有效期12个月，禁止冷冻； 2.开瓶后试剂在2℃ ~ 8℃避光保存，有效期28天； 3.复溶后的校准品2℃ ~ 8℃避光保存，注意挥发，有效期7天； 4.复溶后的质控品2℃ ~ 8℃避光保存，注意挥发，有效期7天。