210423
B
current
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropinไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ฒ็ถ่ บๆฟ็ด ใไฟ็ฒ็ถ่ บ็ด
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin. 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, Thyrotropin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ็ฒ็ถ่ บๆฟ็ด ใไฟ็ฒ็ถ่ บ็ด
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19865
Product Code Detail
19865 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Immunotech SAS, A Beckman Coulter Company
Beckman Coulter, Inc.
France
ๆณๅฝ
130 Avenue de Lattre de Tassigny, BP 177, Marseille, Cedex 9, 13276, France
130 Avenue de Lattre de Tassigny, BP 177, ้ฉฌ่ต, Cedex 9, 13276, ๆณๅฝ
Authorised Representative (AR)
Beckman Coulter Hong Kong Limited
่ดๅ
ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ
ฌๅธ
28147431
Regulatory Timeline
Registration Date
September 20, 2024
Expiry Date
January 17, 2027
Product Models
Access TSH (3rd IS) Reagent Packs (B63284, C28643), Access TSH (3rd IS) Calibrators (B63285)
่ทๅ TSH(็ฌฌ 3 ไธช IS)่ฏๅๅ
(B63284ใC28643)ใ่ฎฟ้ฎ TSH(็ฌฌ 3 ไธช IS)ๆ กๅๅ (B63285)