Taiwan FDA registration 3d349e59d792f9a69e6a0b0ac6025bfb

Apex immunoglobulin M test set

TW: 亞培免疫球蛋白M檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT GMBH·Registered Apr 02, 2019 – Apr 02, 2029Active
Registration details
Analysis ID
3d349e59d792f9a69e6a0b0ac6025bfb
Customs Code
DHA05603239708
Company information
Manufacturer Country
United States;;Germany
Product details
Intended Use
This product is used with the Alinity c analyzer to quantitatively detect immunoglobulin M in human serum or plasma.
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
Input;; Contract manufacturing
Dates and status
Registration Date
Apr 02, 2019
Expiry Date
Apr 02, 2029
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About this record

Access comprehensive regulatory information for Apex immunoglobulin M test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3d349e59d792f9a69e6a0b0ac6025bfb and manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT GMBH. 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 ABBOTT IRELAND DIAGNOSTICS DIVISION, 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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