240424
B
current
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing Hormoneไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็,ๅ ็ซๆตๅฎ,็่ฒๆฟ็ด ,้ปไฝ็ๆ็ด
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing 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, Luteinizing Hormone
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็,ๅ ็ซๆตๅฎ,็่ฒๆฟ็ด ,้ปไฝ็ๆ็ด
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19117
Product Code Detail
19117 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing 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 hLH (33510), Access hLH Calibrators (33515)
Access hLH (33510), Access hLH ๆ กๅๅจ (33515)