Taiwan FDA registration 8c9cb61e362f5a96c2d6db083a051710

Apex complement C3 assay group

TW: 亞培補體C3檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·Made (部分製程) in JAPAN;; ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Sep 22, 2021 – Sep 22, 2026Active
Registration details
Analysis ID
8c9cb61e362f5a96c2d6db083a051710
Customs Code
DHA05603490906
Company information
Manufacturer Country
Ireland;;Japan
Product details
Intended Use
This product is used to quantify C3 in human serum or plasma on the Alinity c System.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.5240 補體成份免疫試驗系統
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Sep 22, 2021
Expiry Date
Sep 22, 2026
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About this record

Access comprehensive regulatory information for Apex complement C3 assay group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8c9cb61e362f5a96c2d6db083a051710 and manufactured by Made (部分製程) in JAPAN;; ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT GMBH, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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