Pure Global

Abbott D-dimer Assay Set - Taiwan Registration 8400fc5945c88d9a853be697702dbdc8

Access comprehensive regulatory information for Abbott D-dimer Assay Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8400fc5945c88d9a853be697702dbdc8 and manufactured by BIOKIT, S.A.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details. 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.

Free Database
Powered by Pure Global AI
89,000+ Devices
8400fc5945c88d9a853be697702dbdc8
Registration Details
Taiwan FDA Registration: 8400fc5945c88d9a853be697702dbdc8
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

Abbott D-dimer Assay Set
TW: ไบžๅŸน D-ไบŒ่š้ซ”ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

8400fc5945c88d9a853be697702dbdc8

DHA05603624202

Company Information

Product Details

This product is intended for the quantitative detection of D-dimer in human citrate plasma on the Alinity c System

B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.7320 Analysis of pro-fiber/fiber-based protein disintegration products

Input;; QMS/QSD

Dates and Status

Dec 15, 2023

Dec 15, 2028