Taiwan FDA registration ddc64365dd7e15b7c0a23f955747f839
"Siemens" immunoglobulin free light chain latex reagent
TW: “西門子”免疫球蛋白游離輕鏈乳膠試劑
Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Registered Aug 15, 2012 – Aug 15, 2017CancelledRegistration details
- Analysis ID
- ddc64365dd7e15b7c0a23f955747f839
- Customs Code
- DHA00602384209
Company information
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- SIEMENS LIMITED
Product details
- Intended Use
- With BN II or BNProSpec systems, particle-enhanced immunoturbidimetry was used to quantitatively detect the concentrations of kappa or lambda free light chains (FLCs) in human serum, heparinized plasma and EDTA plasma.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5550 Immunoglobulin (Specific Light Chain) Immunoassay System
- Import Information
- import
Dates and status
- Registration Date
- Aug 15, 2012
- Expiry Date
- Aug 15, 2017
- Cancellation Date
- Dec 13, 2019
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Siemens" immunoglobulin free light chain latex reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ddc64365dd7e15b7c0a23f955747f839 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH. The authorized representative in Taiwan is SIEMENS LIMITED.
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