Taiwan FDA registration 0d44e8849cc4c313a73226e0c04a7716
Bondesrunda type human immunoglobulin G light chain analysis kit
TW: 邦迪斯倫達型人類免疫球蛋白G輕鏈分析套組
Registration details
- Analysis ID
- 0d44e8849cc4c313a73226e0c04a7716
- Customs Code
- DHA05603114900
Company information
- Manufacturer
- THE BINDING SITE GROUP LTD
- Manufacturer Country
- United Kingdom
- Authorized Representative
- EVERLIGHT BIOTECH(TAIWAN) CO., LTD.
Product details
- Intended Use
- This product must be used with a SPAPLUS analyzer for the quantification of Lunda-type human immunoglobulin G light chain (IgG lambda) in human serum.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- C.5510 免疫球蛋白A,G,M,D及E免疫試驗系統;; A.1660 品管材料(分析與非分析);; A.1150 校正品
- Import Information
- import
Dates and status
- Registration Date
- Jun 14, 2018
- Expiry Date
- Jun 14, 2023
About this record
Access comprehensive regulatory information for Bondesrunda type human immunoglobulin G light chain analysis kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0d44e8849cc4c313a73226e0c04a7716 and manufactured by THE BINDING SITE GROUP LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..
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