Pure Global
190265
D
Expired.

IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibodyไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไธ™ๅž‹่‚็‚Žใ€ๆŠ—ไฝ“

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

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

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17914
Product Code Detail
17914 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Siemens Healthcare Diagnostics Inc
Siemens Healthcare Diagnostics Inc
United States
็พŽๅ›ฝ
511 Benedict Avenue, Tarrytown, New York 10591, USA
511 Benedict Avenue, Tarrytown, New York 10591, USA
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้—จๅญๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
25833388
Regulatory Timeline
Registration Date
August 02, 2019
Expiry Date
August 02, 2024
Product Models
Atellica IM Hepatitis C (10995456), Atellica IM Hepatitis C Quality Control (10995457)
Atellica IM ไธ™ๅž‹่‚็‚Ž (10995456), Atellica IM ไธ™ๅž‹่‚็‚Ž่ดจ้‡ๆŽงๅˆถ (10995457)