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“Siemens” N Latex FLC kappa and N Latex FLC lambda - Taiwan Registration 8cb29015a8ee1dd12e5b35db652dafdd

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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8cb29015a8ee1dd12e5b35db652dafdd
Registration Details
Taiwan FDA Registration: 8cb29015a8ee1dd12e5b35db652dafdd
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Device Details

“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
Risk Class 2
MD

Registration Details

8cb29015a8ee1dd12e5b35db652dafdd

Ministry of Health Medical Device Import No. 027197

DHA05602719706

Company Information

Product Details

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.

C Immunology and microbiology devices

C5550 Immunoglobulin (Specific Light Chain) Immunoassay System

Imported from abroad

Dates and Status

Apr 01, 2015

Apr 01, 2025