Pure Global
240332
D
current

IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typingไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ๆ’ๆฒณ็Œดๅˆ†ๅž‹

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing. 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, Immunohematology, Blood Grouping, Rhesus Typing

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ๆ’ๆฒณ็Œดๅˆ†ๅž‹

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19296
Product Code Detail
19296 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Bio-Rad Medical Diagnostics GmbH
Bio-Rad Medical Diagnostics GmbH
Germany
ๅพทๅ›ฝ
lndustriestr. 1, 63303 Dreieich, Germany
ๅทฅไธš1, 63303 Dreieich, ๅพทๅ›ฝ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
August 08, 2024
Expiry Date
August 07, 2029
Product Models
Seraclone Anti-D (RH1) 226 (802039, 802042)
SeracloneๆŠ—D(RH1)226(802039,802042)