Taiwan FDA registration 0325f32675ec25f6a173cd3ec19234a1

Pson HIV antigen-antibody detection reagent

TW: 普生愛滋抗原-抗體檢測試劑

Taiwan·Risk Class 3·GENERAL BIOLOGICALS CORP.·Registered Mar 14, 2023 – Mar 14, 2028Active

Registration details

Analysis ID: 0325f32675ec25f6a173cd3ec19234a1

Company information

Manufacturer: GENERAL BIOLOGICALS CORP.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: GENERAL BIOLOGICALS CORP.

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Mar 14, 2023
Expiry Date: Mar 14, 2028

About this record

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..

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