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 September 28, 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, LLC
Biofire Diagnostics, Llc
Country: United States
美国
Address: 515 Colorow Drive, Salt Lake City, Utah, 84108, USA
515 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: September 28, 2021
Expiry date: September 28, 2026

Product models

BioFire Respiratory Panel 2.1 (RP 2.1) (423742)

生物火呼吸面板 2.1 (RP 2.1) (423742)

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