220039
B
current
IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin Dไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ปด็็ด ใD ไปฃ่ฐข็ฉใ25-็พๅบ็ปด็็ด D
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D. 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, Vitamin, D Metabolite, 25-Hydroxyvitamin D
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ปด็็ด ใD ไปฃ่ฐข็ฉใ25-็พๅบ็ปด็็ด D
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19142
Product Code Detail
19142 IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D
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
้ท้ปๅคง้ๅธ้ทไบ,ๅ ๅฉ็ฆๅฐผไบๅท,CA 92821,็พๅฝ
Authorised Representative (AR)
Beckman Coulter Hong Kong Limited
่ดๅ
ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ
ฌๅธ
28147431
Regulatory Timeline
Registration Date
July 24, 2024
Expiry Date
February 08, 2027
Product Models
Access 25(OH) Vitamin D Total (Reagent Pack) (A98856, B24838, C28646), Access 25(OH) Vitamin D Total (Calibrators) (A98857, B24839)
Access 25(OH) ็ปด็็ด D ๆป้(่ฏๅๅ
)(A98856ใB24838ใC28646)ใAccess 25(OH) ็ปด็็ด D ๆป้(ๆ กๅๅ)(A98857ใB24839)