IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol

体外诊断测试试剂/试剂盒、免疫测定、肾脏代谢、皮质醇

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

Device overview

Risk class: B
Product code: 19131
State: current
Status: N/A
Product code detail: 19131 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol

Manufacturer (製造商)

Name: Beckman Coulter, Inc.
Beckman Coulter, Inc.
Country: United States
美国
Address: 250 South Kraemer Blvd, Brea, California, 92821, USA
250南克雷默大道, 布雷亚, 加利福尼亚州, 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: September 27, 2026

Product models

Access Cortisol (Reagent Pack) (33600), Access Cortisol (Calibrators) (33605), Access Cortisol (Calibrator S0) (33606)

Access 皮质醇(试剂包) (33600), Access 皮质醇(校准品) (33605), Access 皮质醇(校准品 S0) (33606)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol. 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, Renal Metabolism, Cortisol

產品資訊： 体外诊断测试试剂/试剂盒、免疫测定、肾脏代谢、皮质醇