210352
B
current
IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisolไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่พ่ไปฃ่ฐขใ็ฎ่ดจ้
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol. 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, Renal Metabolism, Cortisol
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่พ่ไปฃ่ฐขใ็ฎ่ดจ้
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19131
Product Code Detail
19131 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol
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
July 24, 2024
Expiry Date
September 27, 2026
Product Models
Access Cortisol (Reagent Pack) (33600), Access Cortisol (Calibrators) (33605), Access Cortisol (Calibrator S0) (33606)
Access ็ฎ่ดจ้(่ฏๅๅ
) (33600), Access ็ฎ่ดจ้(ๆ กๅๅ) (33605), Access ็ฎ่ดจ้(ๆ กๅๅ S0) (33606)