IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Phosphatase

体外诊断测试试剂/试剂盒、免疫测定、骨代谢标志物、骨碱性磷酸酶

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

Device overview

Risk class: B
Product code: 19889
State: current
Status: N/A
Product code detail: 19889 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Phosphatase

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: April 09, 2026

Product models

Access Ostase (Reagent Pack) (37300), Access Ostase (Calibrators) (37305), Access Ostase (QC) (37309)

通路淀粉酶(试剂包) (37300), 接触淀粉(校准品) (37305), 通路淀粉 (QC) (37309)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Phosphatase. 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, Bone Metabolism Marker, Bone Alkaline Phosphatase

產品資訊： 体外诊断测试试剂/试剂盒、免疫测定、骨代谢标志物、骨碱性磷酸酶