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Abbott EB virality test reagent - Taiwan Registration 462b64b1684f7864b5ad7b33df533285

Access comprehensive regulatory information for Abbott EB virality 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 462b64b1684f7864b5ad7b33df533285 and manufactured by ABBOTT MOLECULAR INC.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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462b64b1684f7864b5ad7b33df533285
Registration Details
Taiwan FDA Registration: 462b64b1684f7864b5ad7b33df533285
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Device Details

Abbott EB virality test reagent
TW: ไบžๅŸนEB็—…ๆฏ’้‡ๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2

Registration Details

462b64b1684f7864b5ad7b33df533285

DHA05603617803

Company Information

Product Details

This product is used to quantify Epstein-Barr virus (EBV) DNA in human EDTA plasma by in vitro polymerase chain reaction (PCR) analysis on the automated Alinity m system.

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

A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; C.3235 EB Disease Poison Serum Sample

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

May 23, 2023

May 23, 2028