Taiwan FDA registration 0a2e1beeac919e7d9faa013c1d8132af

Abbott clinical biochemical immunoglobulin M assay group

TW: 亞培臨床生化免疫球蛋白M檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Dec 21, 2021 – Dec 21, 2026Active
Registration details
Analysis ID
0a2e1beeac919e7d9faa013c1d8132af
Customs Code
DHA05603492402
Company information
Manufacturer Country
Ireland
Product details
Intended Use
This product is used to quantify IgM in human serum or plasma on the ARCHITECT c System.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.5510 免疫球蛋白A,G,M,D及E免疫試驗系統
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Dec 21, 2021
Expiry Date
Dec 21, 2026
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About this record

Access comprehensive regulatory information for Abbott clinical biochemical immunoglobulin M 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 0a2e1beeac919e7d9faa013c1d8132af and manufactured by 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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