240425
C
current
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroglobulinไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ฒ็ถ่ บๆฟ็ด ใ็ฒ็ถ่ บ็่็ฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroglobulin. 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, Thyroid Hormone, Thyroglobulin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ฒ็ถ่ บๆฟ็ด ใ็ฒ็ถ่ บ็่็ฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
17398
Product Code Detail
17398 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroglobulin
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
250 South Kraemer Blvd., Brea, California, 92821 USA
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 Thyroglobulin (C71762), Access Thyroglobulin Calibrators (33865), Access Thyroglobulin Sample Diluent (33866)
Access ็ฒ็ถ่
บ็่็ฝ (C71762)ใAccess ็ฒ็ถ่
บ็่็ฝๆ กๅๅ (33865)ใAccess ็ฒ็ถ่
บ็่็ฝๆ ทๅ็จ้ๆถฒ (33866)