Pure Global
210367
C
current

IVD Test Reagent/Kits, Molecular Assay, Infectionไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅˆ†ๅญๆฃ€ๆต‹ใ€ๆ„ŸๆŸ“

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

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅˆ†ๅญๆฃ€ๆต‹ใ€ๆ„ŸๆŸ“

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19237
Product Code Detail
19237 IVD Test Reagent/Kits, Molecular Assay, Infection
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
BioFire Diagnostics, LLC
Biofire Diagnostics, Llc
United States
็พŽๅ›ฝ
515 Colorow Drive, Salt Lake City, Utah, 84108, USA
515 Colorow Drive, ็›ๆน–ๅŸŽ, ็Šนไป–ๅทž, 84108, ็พŽๅ›ฝ
Authorised Representative (AR)
BioMerieux China Ltd.
็”Ÿ็‰ฉๆข…้‡ŒๅŸƒไธญๅ›ฝๆœ‰้™ๅ…ฌๅธ
23567033
Regulatory Timeline
Registration Date
September 28, 2021
Expiry Date
September 28, 2026
Product Models
BioFire Respiratory Panel 2.1 (RP 2.1) (423742)
็”Ÿ็‰ฉ็ซๅ‘ผๅธ้ขๆฟ 2.1 (RP 2.1) (423742)