240436
C
current
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Prolactinไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็่ฒๆฟ็ด ใๅฌไนณ็ด
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Prolactin. 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, Prolactin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็่ฒๆฟ็ด ใๅฌไนณ็ด
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19119
Product Code Detail
19119 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Prolactin
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
250ๅๅ
้ท้ปๅคง้,ๅธ้ทไบ,ๅ ๅฉ็ฆๅฐผไบๅท,92821,็พๅฝ
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 Prolactin (Reagent Pack) (33530), Access Prolactin (Calibrators) (33535)
Access ๅฌไนณ็ด (่ฏๅๅ
) (33530)ใAccess ๅฌไนณ็ด (ๆ กๅๅ) (33535)