210105
B
current
IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Phosphataseไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ้ชจไปฃ่ฐขๆ ๅฟ็ฉใ้ชจ็ขฑๆง็ฃท้ ธ้ ถ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Phosphatase. 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, Bone Metabolism Marker, Bone Alkaline Phosphatase
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ้ชจไปฃ่ฐขๆ ๅฟ็ฉใ้ชจ็ขฑๆง็ฃท้ ธ้ ถ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19889
Product Code Detail
19889 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Phosphatase
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Beckman Coulter, Inc.
Beckman Coulter, Inc.
United States
็พๅฝ
250 South Kraemer Blvd., Brea, California CA 92821, USA
250ๅๅ
้ท้ปๅคง้,ๅธ้ทไบ,ๅ ๅฉ็ฆๅฐผไบๅทCA 92821,็พๅฝ
Authorised Representative (AR)
Beckman Coulter Hong Kong Limited
่ดๅ
ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ
ฌๅธ
28147431
Regulatory Timeline
Registration Date
July 24, 2024
Expiry Date
April 09, 2026
Product Models
Access Ostase (Reagent Pack) (37300), Access Ostase (Calibrators) (37305), Access Ostase (QC) (37309)
้่ทฏๆท็ฒ้
ถ(่ฏๅๅ
) (37300), ๆฅ่งฆๆท็ฒ(ๆ กๅๅ) (37305), ้่ทฏๆท็ฒ (QC) (37309)