IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen

体外诊断检测试剂/试剂盒, 免疫测定, 快速检测, 细菌, 肺炎链球菌, 抗原

Abbott Diagnostics Scarborough, Inc.·C·Hong Kong MDACS·Registered July 23, 2024

Device overview

Risk class: C
Product code: N/A
State: current
Status: N/A

Manufacturer (製造商)

Name: Abbott Diagnostics Scarborough, Inc.
Abbott
Country: United States
美国
Address: 10 Southgate Road, Scarborough, ME 04074, United States Of America
10 Southgate Road, 斯卡伯勒, ME 04074, 美国

Authorised representative (AR)

Name: Abbott Laboratories Limited
美国雅培制药有限公司
Phone: 25668711, 98615786

Regulatory timeline

Registration date: July 23, 2024
Expiry date: July 22, 2029

Product models

BinaxNOW Streptococcus pneumoniae Antigen Card (710-100, 710-012), BinaxNOW Streptococcus pneumoniae Control Swab Pack (710-010)

BinaxNOW 肺炎链球菌抗原卡 (710-100, 710-012), BinaxNOW 肺炎链球菌对照拭子包 (710-010)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen. 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.