Taiwan FDA registration c640cc24df536fedee8fe88c6321d329
Amplichek I
TW: 安必測 核酸測試品管液
Taiwan·Risk Class 2·MD·BIO-RAD LABORATORIES·Registered Sep 01, 2017 – Sep 01, 2027ActiveRegistration details
- Analysis ID
- c640cc24df536fedee8fe88c6321d329
- License Form
- Ministry of Health Medical Device Import No. 029840
- Customs Code
- DHA05602984002
Company information
- Manufacturer
- BIO-RAD LABORATORIES
- Manufacturer Country
- United States
- Authorized Representative
- Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.)
Product details
- Intended Use
- This product uses an external analytical quality control reagent to monitor nucleic acid testing procedures for HIV-1, hepatitis B virus and hepatitis C virus in the molecular diagnostic platform in vitro laboratories.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 01, 2017
- Expiry Date
- Sep 01, 2027
About this record
Access comprehensive regulatory information for Amplichek I in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c640cc24df536fedee8fe88c6321d329 and manufactured by BIO-RAD LABORATORIES. The authorized representative in Taiwan is Bio-Rad Laboratories Inc., 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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