Pure Global
140223
D
current

IVD Test Reagent/Kits, Serology, Control, Virusไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€ๅฏน็…งใ€็—…ๆฏ’

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Control, Virus. 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, Serology, Control, Virus

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€ๅฏน็…งใ€็—…ๆฏ’

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17068
Product Code Detail
17068 IVD Test Reagent/Kits, Serology, Control, Virus
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
BIO RAD LABORATORIES, Clinical Diagnostics Group
BIO RAD LABORATORIES, Clinical Diagnostics Group
9500 Jeronimo Road, IRVINE, CALIFORNIA 92618-2017, UNITED STATES
9500 Jeronimo Road, ๅฐ”ๆนพๅธ‚, CALIFORNIA 92618-2017, ็พŽๅ›ฝ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
May 22, 2024
Expiry Date
July 22, 2029
Product Models
Assayed VIROTROL I-C (00164), Assayed VIROTROL I-E (00166), Assayed VIROTROL I-F (00168)
ๅŒ–้ชŒ็ปด็ฝ—็‰น็ฝ—I-C (00164), ๅŒ–้ชŒ็ปด็ฝ—็‰น็ฝ—I-E (00166), ๅŒ–้ชŒ็ปด็ฝ—็ฝ—็ฝ—I-F (00168)