210101
B
current
IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietinไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ดซ่กๆฃๆตใไฟ็บข็ป่็ๆ็ด
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin. 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, Anemia Test, Erythropoietin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ดซ่กๆฃๆตใไฟ็บข็ป่็ๆ็ด
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19137
Product Code Detail
19137 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin
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
March 18, 2026
Product Models
Access EPO (Reagent Pack) (A16364), Access EPO (Calibrators) (A16365)
่ฎฟ้ฎ EPO(่ฏๅๅ
) (A16364),่ฎฟ้ฎ EPO(ๆ กๅๅ) (A16365)