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Pson HIV antigen-antibody detection reagent - Taiwan Registration 0325f32675ec25f6a173cd3ec19234a1

Access comprehensive regulatory information for Pson HIV antigen-antibody detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 0325f32675ec25f6a173cd3ec19234a1 and manufactured by GENERAL BIOLOGICALS CORP.. The authorized representative in Taiwan is GENERAL BIOLOGICALS CORP..

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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0325f32675ec25f6a173cd3ec19234a1
Registration Details
Taiwan FDA Registration: 0325f32675ec25f6a173cd3ec19234a1
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Device Details

Pson HIV antigen-antibody detection reagent
TW: ๆ™ฎ็”Ÿๆ„›ๆป‹ๆŠ—ๅŽŸ-ๆŠ—้ซ”ๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 3

Registration Details

0325f32675ec25f6a173cd3ec19234a1

Company Information

Taiwan, Province of China

Product Details

This product is an in vitro diagnostic reagent of enzyme immunoassay using antigen and antibody mixed plated plate for the detection of human immunodeficiency virus type 1 and type 2 antibodies and their antigens (HIV-1 p24) in human serum or plasma (anticoagulants containing heparin, EDTA, or citric acid). Not suitable for blood donor screening.

B Hematology, pathology, and genetics

B.4020 Analysis of specific tests

ๅœ‹็”ข;; QMS/QSD

Dates and Status

Mar 14, 2023

Mar 14, 2028