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Abbott antistreptolysin O and rheumatoid factor quality control solution - Taiwan Registration dae45b85c48b4f84d8eabc70395cadd3

Access comprehensive regulatory information for Abbott antistreptolysin O and rheumatoid factor quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dae45b85c48b4f84d8eabc70395cadd3 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.

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dae45b85c48b4f84d8eabc70395cadd3
Registration Details
Taiwan FDA Registration: dae45b85c48b4f84d8eabc70395cadd3
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Device Details

Abbott antistreptolysin O and rheumatoid factor quality control solution
TW: ไบžๅŸนๆŠ—้ˆ็ƒ่Œๆบถ่ก€็ด OๅŠ้กž้ขจๆฟ•ๅ› ๅญๅ“็ฎกๆถฒ็ต„
Risk Class 2

Registration Details

dae45b85c48b4f84d8eabc70395cadd3

DHA05603348102

Company Information

Product Details

This product is used to monitor the quality management of the results of the "Apepto" antistreptolysin O test set (unsterilized) and the Apex rheumatoid factor test set obtained by the turbidimetric method. This product should be used with the "Apbot" Antistreptolysin O Test Set (Unsterilized) and the Apex Rheumatoid Factor Test Set on the Alinity c Analyzer.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical)

import

Dates and Status

May 12, 2020

May 12, 2030