6 Devices
BioFire Diagnostics, LLC - Applicant Profile
Biofire Diagnostics, Llc
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.
1 Risk Classes
Since 2021
Latest 2022
Applicant Overview
Bilingual manufacturer details sourced from Hong Kong MDACS.
Applicant (EN)
BioFire Diagnostics, LLC
Country
United States
็พๅฝ
Brand
FilmArray Meningitis/Encephalitis (ME) Panel
FilmArray ่่็/่็ (ME) ้ขๆฟ
Applicant (ZH)
Biofire Diagnostics, Llc
Address
515 Colorow Drive, Salt Lake City, Utah, 84108, USA
515 Colorow Drive, ็ๆนๅ, ็นไปๅท, 84108, ็พๅฝ
Recent MDACS Registrations
Latest 15 devices linked to this applicant.
| Device | Risk Class | Authorised Rep | Registered |
|---|---|---|---|
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | May 16, 2022 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Sep 28, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | May 26, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใ้้ป่ฒ่ก่็่ใDNAใๆ่่่ฏๆง | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Apr 09, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Apr 09, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Apr 09, 2021 |
Risk Class Breakdown
C6
Timeline
First Registration
Apr 09, 2021
Most Recent
May 16, 2022