Pure Global
241094
B
current

IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistryไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซ็ป†่ƒžๅŒ–ๅญฆ/ๅ…็–ซ็ป„ๅŒ–

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry. 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, Immunocytochemistry/Immunohistochemistry

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซ็ป†่ƒžๅŒ–ๅญฆ/ๅ…็–ซ็ป„ๅŒ–

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
20007
Product Code Detail
20007 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Ventana Medical Systems, Inc.
Ventana Medical Systems,Inc.
United States
็พŽๅ›ฝ
1910 East Innovation Park Drive, Tucson, AZ 85755, USA
1910 East Innovation Park Drive, ๅ›พๆฃฎ, AZ 85755, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 16, 2024
Expiry Date
October 15, 2029
Product Models
Rabbit Monoclonal Negative Control Ig (06683380001)
ๅ…”ๅ•ๅ…‹้š†้˜ดๆ€งๅฏน็…ง Ig (06683380001)