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Elunma procalcitonin test reagent - Taiwan Registration 34e0ac0d2161546c5dcb96dba40cf90b

Access comprehensive regulatory information for Elunma procalcitonin test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 34e0ac0d2161546c5dcb96dba40cf90b and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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34e0ac0d2161546c5dcb96dba40cf90b
Registration Details
Taiwan FDA Registration: 34e0ac0d2161546c5dcb96dba40cf90b
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Device Details

Elunma procalcitonin test reagent
TW: ่‰พๆฟถ็‘ชๅ‰้™้ˆฃ็ด ๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2

Registration Details

34e0ac0d2161546c5dcb96dba40cf90b

DHA05603589105

Company Information

Korea, Republic of

Product Details

This product is a fluorescent immunoassay (FIA) for the quantitative determination of procalcitonin in human whole blood/serum/plasma.

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

C.3210 Endotoxin Analysis Test;; A.1660 Quality control materials (analytical and non-analytical)

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Dec 07, 2022

Dec 07, 2027