240337
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)
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Lisnamuck, Longford, Co. Longford, IRELAND
Lisnamuck, Longford, Co. ๆ็ฆๅพท, ็ฑๅฐๅ
ฐ
Authorised Representative (AR)
Abbott Laboratories Limited
็พๅฝ้
ๅนๅถ่ฏๆ้ๅ
ฌๅธ
25668711, 98615786
Regulatory Timeline
Registration Date
August 08, 2024
Expiry Date
August 07, 2029
Product Models
ARCHITECT TSH Reagent Kit (7K62-25, 7K62-30, 7K62-35), ARCHITECT TSH Calibrators (7K62-01), ARCHITECT TSH Controls (7K62-10)
ARCHITECT TSH ่ฏๅ็ (7K62-25ใ7K62-30ใ7K62-35)ใARCHITECT TSH ๆ กๅๅ (7K62-01)ใARCHITECT TSH ๅฏน็
งๅ (7K62-10)