240437
C
current
IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Betaไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ๅฆๅจ ๆฟ็ด , ไบบ็ปๆฏ่ไฟๆง่ บๆฟ็ด , ฮฒ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta. 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, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ๅฆๅจ ๆฟ็ด , ไบบ็ปๆฏ่ไฟๆง่ บๆฟ็ด , ฮฒ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19124
Product Code Detail
19124 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta
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 Total ฮฒhCG (5th IS) (Reagent Pack) (A85264, C28645), Access Total ฮฒhCG (5th IS) (Calibrator) (B11754)
Access ๆป ฮฒhCG(็ฌฌ 5 ไธช IS)(่ฏๅๅ
)(A85264ใC28645)ใAccess ๆป ฮฒhCG(็ฌฌ 5 ไธช IS)(ๆ กๅๅ)(B11754)