240340
B
current
IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๅๆใ่ช่บซๅ ็ซใ็ฒ็ถ่ บใ่ฟๆฐงๅ็ฉ้ ถๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibody. 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, Autoimmune, Thyroid, Peroxidase Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๅๆใ่ช่บซๅ ็ซใ็ฒ็ถ่ บใ่ฟๆฐงๅ็ฉ้ ถๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
20098
Product Code Detail
20098 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibody
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 TPO Ab (Reagent Pack) (A12985), Access TPO Ab (Calibrators) (A18227)
ๆฅ่งฆ TPO ๆไฝ(่ฏๅๅ
) (A12985), ๆฅ่งฆ TPO ๆไฝ(ๆ กๅๅ) (A18227)