Applicant profile
BioFire Diagnostics, LLC
Biofire Diagnostics, Llc
Hong Kong MDACS·United States·6 registered devices·Apr 09, 2021 – May 16, 2022
6
Total devices
1
Risk classes
2021
First registration
2022
Most recent
Applicant overview
Bilingual manufacturer details sourced from Hong Kong MDACS
- Applicant (EN)
- BioFire Diagnostics, LLC
- Applicant (ZH)
- Biofire Diagnostics, Llc
- Country
- United States美国
- Brand
- FilmArray Meningitis/Encephalitis (ME) PanelFilmArray 脑膜炎/脑炎 (ME) 面板
- Address
- 515 Colorow Drive, Salt Lake City, Utah, 84108, USA515 Colorow Drive, 盐湖城, 犹他州, 84108, 美国
Timeline
- First registration
- Apr 09, 2021
- Most recent
- May 16, 2022
Risk class breakdown
C
6
Recent MDACS registrations
Latest 15 devices linked to this applicant
| Device | Risk class | Authorised rep | Registered |
|---|---|---|---|
| IVD Test Reagent/Kits, Molecular Assay, Infection 体外诊断 检测试剂/试剂盒、分子检测、感染 | C | BioMerieux China Ltd. 生物梅里埃中国有限公司 | May 16, 2022 |
| IVD Test Reagent/Kits, Molecular Assay, Infection 体外诊断 检测试剂/试剂盒、分子检测、感染 | C | BioMerieux China Ltd. 生物梅里埃中国有限公司 | Sep 28, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection 体外诊断 检测试剂/试剂盒、分子检测、感染 | C | BioMerieux China Ltd. 生物梅里埃中国有限公司 | May 26, 2021 |
| 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 | C | BioMerieux China Ltd. 生物梅里埃中国有限公司 | Apr 09, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection 体外诊断 检测试剂/试剂盒、分子检测、感染 | C | BioMerieux China Ltd. 生物梅里埃中国有限公司 | Apr 09, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection 体外诊断 检测试剂/试剂盒、分子检测、感染 | C | BioMerieux China Ltd. 生物梅里埃中国有限公司 | Apr 09, 2021 |
About this profile
BioFire Diagnostics, LLC is associated with 6 medical devices registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.