Pure Global
241078
B
current

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

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

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

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
32974
Product Code Detail
32974 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Stain
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 E Innovation Park Drive, Tucson, AZ 85755, USA
1910 E 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
Alu Positive Control Probe (05278694001)
้“้˜ณๆ€งๅฏน็…งๆŽข้’ˆ (05278694001)