Taiwan FDA registration e3b8caaab9608f821a0185ede7a34c34

Beckman Coulter homocysteine assay reagent

TW: 貝克曼庫爾特同半胱胺酸分析試劑
Taiwan flagTaiwan·Risk Class 2·AXIS-SHIELD DIAGNOSTICS LTD.·Registered Dec 21, 2012 – Dec 21, 2022Cancelled
Registration details
Analysis ID
e3b8caaab9608f821a0185ede7a34c34
Customs Code
DHA00602430004
Company information
Manufacturer Country
United Kingdom
Product details
Intended Use
This product is used in the SYNCHRON LX 20 PRO, UniCel DxC600 and UniCel DxC800 systems to quantitatively detect total homocysteine concentrations in human serum and plasma in vitro.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1377 Cystine-like non-quantitative testing system in urine
Import Information
import
Dates and status
Registration Date
Dec 21, 2012
Expiry Date
Dec 21, 2022
Cancellation Date
Apr 12, 2024
Cancellation information
Status
Logged out
Reason
許可證已逾有效期
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About this record

Access comprehensive regulatory information for Beckman Coulter homocysteine assay reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e3b8caaab9608f821a0185ede7a34c34 and manufactured by AXIS-SHIELD DIAGNOSTICS LTD.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Axis-Shield Diagnostics Limited, 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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