200384
IVD Test Reagent/Kits, Molecular Assay, Infection
体外诊断 检测试剂/试剂盒、分子检测、感染
BioFire Diagnostics, LLC·C·Hong Kong MDACS·Registered May 26, 2021
Device overview
- Risk class
- C
- Product code
- 19237
- State
- current
- Status
- N/A
- Product code detail
- 19237 IVD Test Reagent/Kits, Molecular Assay, Infection
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
- May 26, 2021
- Expiry date
- November 18, 2025
Product models
FilmArray Gastrointestinal (GI) Panel (RFIT-ASY-0104, RFIT-ASY-0116)
FilmArray 胃肠道 (GI) 面板 (RFIT-ASY-0104, RFIT-ASY-0116)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection. 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
產品資訊： 体外诊断 检测试剂/试剂盒、分子检测、感染