IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody

体外诊断检测试剂/试剂盒, 血清学, 病毒, 严重急性呼吸综合征冠状病毒 2, 抗体

Roche Diagnostics GmbH·C·Hong Kong MDACS·Registered October 16, 2024

Device overview

Risk class: C
Product code: 41674
State: current
Status: N/A
Product code detail: 41674 IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody

Manufacturer (製造商)

Name: Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Country: Germany
德国
Address: Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 曼海姆, 德国

Authorised representative (AR)

Name: Roche Diagnostics (Hong Kong) Limited
Phone: 24813387

Regulatory timeline

Registration date: October 16, 2024
Expiry date: October 15, 2029

Product models

Elecsys Anti-SARS-CoV-2 (09203079190, 09203095190), PreciControl Anti-SARS-CoV-2 (09216928190)

Elecsys 抗 SARS-CoV-2 (09203079190, 09203095190), PreciControl 抗 SARS-CoV-2 (09216928190)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody. 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, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody

產品資訊： 体外诊断检测试剂/试剂盒, 血清学, 病毒, 严重急性呼吸综合征冠状病毒 2, 抗体