240335
B
current
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Freeไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็,ๅ ็ซๆตๅฎ,็ฒ็ถ่ บๆฟ็ด ,็ฒ็ถ่ บ็ด ,ๆธธ็ฆป
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Free. 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, Thyroxin, Free
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็,ๅ ็ซๆตๅฎ,็ฒ็ถ่ บๆฟ็ด ,็ฒ็ถ่ บ็ด ,ๆธธ็ฆป
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19111
Product Code Detail
19111 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Free
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
August 08, 2024
Expiry Date
August 07, 2029
Product Models
Access Free T4 (Reagent Pack) (33880), Access Free T4 (Calibrators) (33885)
Access Free T4(่ฏๅๅ
) (33880),Access Free T4(ๆ กๅๅ) (33885)