Pure Global
150335
D
Expired.

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

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

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

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19295
Product Code Detail
19295 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
DiaMed Holding GmbH
DiaMed Holding GmbH
Switzerland
็‘žๅฃซ
Pra Rond 23, 1785 Cressier FR, Switzerland
Pra Rond 23, 1785 ๅ…‹้›ท่ฅฟ่€ถ่”้‚ฆๅ…ฌๆŠฅ, ็‘žๅฃซ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
November 11, 2015
Expiry Date
November 11, 2020
Product Models
Bio-Rad DiaClon Anti-AB (10270), DiaClon Anti-A (10291), DiaClon Anti-B(10301), DiaClon-MP Anti-A (12300), DiaClon-MP Anti-B (12310), DiaClon-MP Anti-AB (12320)
Bio-Rad DiaClon ๆŠ— AB (10270), DiaClon ๆŠ— A (10291), DiaClone ๆŠ— B(10301), DiaClon-MP ๆŠ— A (12300), DiaClon-MP ๆŠ— B (12310), DiaClon-MP ๆŠ— AB (12320)