Taiwan FDA registration 8cb29015a8ee1dd12e5b35db652dafdd
“Siemens” N Latex FLC kappa and N Latex FLC lambda
TW: “西門子” 免疫球蛋白游離輕鏈乳膠試劑
Taiwan·Risk Class 2·MD·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Registered Apr 01, 2015 – Apr 01, 2025ExpiredRegistration details
- Analysis ID
- 8cb29015a8ee1dd12e5b35db652dafdd
- License Form
- Ministry of Health Medical Device Import No. 027197
- Customs Code
- DHA05602719706
Company information
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- In combination with BN II or BN ProSpec system, the concentration of kappa or lambda type free light chain (FLC) in human serum, heparinized plasma, EDTA plasma and urine was quantified by particle enhanced immunoturbidimetry.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5550 Immunoglobulin (Specific Light Chain) Immunoassay System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 01, 2015
- Expiry Date
- Apr 01, 2025
About this record
Access comprehensive regulatory information for “Siemens” N Latex FLC kappa and N Latex FLC lambda in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8cb29015a8ee1dd12e5b35db652dafdd and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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