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"Siemens" immunoglobulin M analysis reagent - Taiwan Registration 8561c6d844ecb45062c3d6deac3b024a

Access comprehensive regulatory information for "Siemens" immunoglobulin M analysis reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8561c6d844ecb45062c3d6deac3b024a and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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8561c6d844ecb45062c3d6deac3b024a
Registration Details
Taiwan FDA Registration: 8561c6d844ecb45062c3d6deac3b024a
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Device Details

"Siemens" immunoglobulin M analysis reagent
TW: โ€œ่ฅฟ้–€ๅญโ€ ๅ…็–ซ็ƒ่›‹็™ฝMๅˆ†ๆž่ฉฆๅŠ‘
Risk Class 2

Registration Details

8561c6d844ecb45062c3d6deac3b024a

DHA05603199701

Company Information

Product Details

This product is used for in vitro diagnosis and needs to be used with Atellica CH Analyzer to quantitatively detect immunoglobulin M (IgM) in human serum and plasma (heparin lithium, EDTA potassium salt).

C Immunology and microbiology

C.5510 ๅ…็–ซ็ƒ่›‹็™ฝA,G,M,DๅŠEๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ

Input;; Contract manufacturing

Dates and Status

Dec 28, 2018

Dec 28, 2028