IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin

体外诊断测试试剂/试剂盒、免疫测定、甲状腺激素、促甲状腺素

Immunotech SAS, A Beckman Coulter Company·B·Hong Kong MDACS·Registered September 20, 2024

Device overview

Risk class: B
Product code: 19865
State: current
Status: N/A
Product code detail: 19865 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin

Manufacturer (製造商)

Name: Immunotech SAS, A Beckman Coulter Company
Beckman Coulter, Inc.
Country: France
法国
Address: 130 Avenue de Lattre de Tassigny, BP 177, Marseille, Cedex 9, 13276, France
130 Avenue de Lattre de Tassigny, BP 177, 马赛, Cedex 9, 13276, 法国

Authorised representative (AR)

Name: Beckman Coulter Hong Kong Limited
贝克曼库尔特香港有限公司
Phone: 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)

获取 TSH(第 3 个 IS)试剂包(B63284、C28643)、访问 TSH(第 3 个 IS)校准品 (B63285)

About this record

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

產品資訊： 体外诊断测试试剂/试剂盒、免疫测定、甲状腺激素、促甲状腺素