Anti-Autoantibody Spectrum 23 Item Antibody IgG Detection Kit (Flow Cytometry)
- Device class
- Class II
- Model specifications
- See attached page 1见附页1
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20232401180
- Approval date
- December 11, 2023
- Expiry date
- December 10, 2028
- Name
- Hunan XieGuang Biotechnology Co., Ltd.湖南携光生物技术有限公司
- Province/Region
- Hunan湖南
- Address
- The 2nd floor of the 2nd building of the medical device industrial park of the high-tech industrial development zone of Jinshi City, Hunan Province湖南省津市市高新技术产业开发区医疗器械产业园第2栋第2层
- Production address
- 湖南省津市市高新技术产业开发区医疗器械产业园第2栋第1层，第2层
This kit is used for the in vitro quantitative detection of IgG autoantibodies to the following antigens in human serum and plasma samples: dsDNA, Sm, His, Nuc, P0, SS-A, SS-B/La, Scl-70, Jo-1, PM-Scl, CENP-B, nRNP/Sm, AMA-M2, ssDNA, C1q, and qualitatively detect IgG autoantibodies for the following antigens in human serum and plasma samples: Ro52, PCNA, Mi-2, Ku, PCA, IF, platelets (APA), α-Fodrin.
本试剂盒用于体外定量检测人血清、血浆样本中下述抗原的IgG类自身抗体：dsDNA、Sm、His、Nuc、P0、SS-A、SS-B/La、Scl-70、Jo-1、PM-Scl、CENP-B、nRNP/Sm、AMA-M2、ssDNA、C1q，以及定性检测人血清、血浆样本中下述抗原的IgG类自身抗体：Ro52、PCNA、Mi-2、Ku、PCA、IF、血小板（APA）、α-Fodrin。
See attached page 2
见附页2
The unopened kit is stored at 2°C~8°C and protected from light for 15 months, and can be stored stably for 56 days at 2°C~8°C after opening. After reconstitution, it can be stored for 56 days at 2°C~8°C. Transportation and storage should be carried out under low temperature conditions of 2°C~8°C.
未开瓶试剂盒于2℃～8℃密闭避光保存有效期为15个月，开瓶后2℃～8℃避光保存可稳定56天。M复溶后在2℃～8℃条件下可保存56天。 运输和保存均应在2℃～8℃低温条件下进行。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Anti-Autoantibody Spectrum 23 Item Antibody IgG Detection Kit (Flow Cytometry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20232401180 and owned by Hunan XieGuang Biotechnology Co., Ltd.. The device was approved on December 11, 2023.
This page provides complete registration details including registrant information, province location (Hunan), 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.