Taiwan FDA registration bd66a4bc97ac7be10ee287d9bdbeb7d5

GB HCV RealQuant PCR

TW: 普生C型肝炎病毒即時定量試劑

Taiwan·Risk Class 3·MD·GENERAL BIOLOGICALS CORP.·Registered Jul 23, 2015 – Jul 23, 2025Expired

Registration details

Analysis ID: bd66a4bc97ac7be10ee287d9bdbeb7d5
License Form: Ministry of Health Medical Device Manufacturing No. 004945

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 nucleic acid amplification test (NAT) for the quantitative detection of RNA of hepatitis C virus (HCV) genotypes 1 to 6 in human serum or plasma (EDTA). The purpose of use of this product is not to be used as a test to screen blood or blood products for HCV, nor as a diagnostic test to confirm the presence of HCV infection, but to quantitatively detect the amount of HCV RNA in the specimen to understand the changes in the HCV RNA amount of the specimen at different time points of the patient.
Product Type (Level 1): B Hematology and pathology devices
Product Type (Level 2): B4020 Analyze specific reagents
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Jul 23, 2015
Expiry Date: Jul 23, 2025

About this record

Access comprehensive regulatory information for GB HCV RealQuant PCR in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number bd66a4bc97ac7be10ee287d9bdbeb7d5 and manufactured by GENERAL BIOLOGICALS CORP.. The authorized representative in Taiwan is GENERAL BIOLOGICALS CORP..

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