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Alinity m Sample Prep Kit 2 - Taiwan Registration 8a57cb1610bf12c02220ff43ff65486d

Access comprehensive regulatory information for Alinity m Sample Prep Kit 2 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8a57cb1610bf12c02220ff43ff65486d and manufactured by ABBOTT MOLECULAR INC.. 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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8a57cb1610bf12c02220ff43ff65486d
Registration Details
Taiwan FDA Registration: 8a57cb1610bf12c02220ff43ff65486d
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Device Details

Alinity m Sample Prep Kit 2
TW: ไบžๅŸนๆจฃๆœฌ่™•็†ๅฅ—็ต„2
Risk Class 2
MD

Registration Details

8a57cb1610bf12c02220ff43ff65486d

Ministry of Health Medical Device Import No. 033515

DHA05603351506

Company Information

Product Details

This product is required for the isolation of nucleic acids from biological samples on the automated Alinity m system for polymerase chain reaction (PCR) detection. For detailed instructions, please refer to the Alinity m System Operation Manual.

C Immunology and microbiology devices

C4070 Ribonucleic acid analysis pretreatment system

Imported from abroad

Dates and Status

Jul 24, 2020

Jul 24, 2025