200390
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant
体外诊断 检测试剂/试剂盒、分子测定、感染、细菌、金黄色葡萄球菌、DNA、抗菌耐药性
BioFire Diagnostics, LLC·C·Hong Kong MDACS·Registered April 09, 2021
Device overview
- Risk class
- C
- Product code
- 21666
- State
- current
- Status
- N/A
- Product code detail
- 21666 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant
Manufacturer (製造商)
- Name
- BioFire Diagnostics, LLCBiofire Diagnostics, Llc
- Country
- United States美国
- Address
- 515 Colorow Drive, Salt Lake City, Utah, 84108, USA515 Colorow Drive, 盐湖城, 犹他州, 84108, 美国
Authorised representative (AR)
- Name
- BioMerieux China Ltd.生物梅里埃中国有限公司
- Phone
- 23567033
Regulatory timeline
- Registration date
- April 09, 2021
- Expiry date
- November 18, 2025
Product models
BioFire Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147)
BioFire 血培养鉴定 2 (BCID2) 面板 (RFIT-ASY-0147)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant
產品資訊： 体外诊断 检测试剂/试剂盒、分子测定、感染、细菌、金黄色葡萄球菌、DNA、抗菌耐药性