200390
C
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistantไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใ้้ป่ฒ่ก่็่ใDNAใๆ่่่ฏๆง
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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใ้้ป่ฒ่ก่็่ใDNAใๆ่่่ฏๆง
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
21666
Product Code Detail
21666 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BioFire Diagnostics, LLC
Biofire Diagnostics, Llc
United States
็พๅฝ
515 Colorow Drive, Salt Lake City, Utah, 84108, USA
515 Colorow Drive, ็ๆนๅ, ็นไปๅท, 84108, ็พๅฝ
Authorised Representative (AR)
BioMerieux China Ltd.
็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ
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 ่กๅนๅ
ป้ดๅฎ 2 (BCID2) ้ขๆฟ (RFIT-ASY-0147)