240423
B
current
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormoneไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็่ฒๆฟ็ด ใไฟๅตๆณกๆฟ็ด
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone. 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, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็่ฒๆฟ็ด ใไฟๅตๆณกๆฟ็ด
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19116
Product Code Detail
19116 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Beckman Coulter, Inc.
Beckman Coulter, Inc.
United States
็พๅฝ
250 South Kraemer Blvd., Brea, California, 92821 USA
250 South Kraemer Blvd., Brea, California, 92821 USA
Authorised Representative (AR)
Beckman Coulter Hong Kong Limited
่ดๅ
ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ
ฌๅธ
28147431
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
Access hFSH (33520), Access hFSH Calibrators (33525)
่ฎฟ้ฎ hFSH (33520),่ฎฟ้ฎ hFSH ๆ กๅๅ (33525)