IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin

体外诊断检测试剂/试剂盒、免疫测定、贫血检测、促红细胞生成素

Beckman Coulter, Inc.·B·Hong Kong MDACS·Registered July 24, 2024

Device overview

Risk class: B
Product code: 19137
State: current
Status: N/A
Product code detail: 19137 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin

Manufacturer (製造商)

Name: Beckman Coulter, Inc.
Beckman Coulter, Inc.
Country: United States
美国
Address: 250 South Kraemer Blvd., Brea, California CA 92821, USA
250南克雷默大道,布雷亚,加利福尼亚州CA 92821,美国

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: July 24, 2024
Expiry date: March 18, 2026

Product models

Access EPO (Reagent Pack) (A16364), Access EPO (Calibrators) (A16365)

访问 EPO(试剂包) (A16364),访问 EPO(校准品) (A16365)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin. 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, Anemia Test, Erythropoietin

產品資訊： 体外诊断检测试剂/试剂盒、免疫测定、贫血检测、促红细胞生成素