240132
C
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Parainfluenza体外诊断检测试剂/试剂盒, 分子检测, 感染, 病毒, 副流感病毒
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Parainfluenza. 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, Molecular Assay, Infection, Virus, Parainfluenza
產品資訊： 体外诊断检测试剂/试剂盒, 分子检测, 感染, 病毒, 副流感病毒
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
22322
Product Code Detail
22322 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Parainfluenza
State
current
Status
N/A
Brand
Panther Fusion Paraflu Assay
豹融合副氟检测
Manufacturer (製造商)
Hologic Inc.
Hologic
10210 Genetic Center Drive, San Diego, California 92121 UNITED STATES
10210遗传中心驱动器, 圣地亚哥, 加利福尼亚州 92121 美国
Authorised Representative (AR)
Hologic Asia Pacific Limited
美国豪洛捷亚太有限公司
37487700
Regulatory Timeline
Registration Date
April 18, 2024
Expiry Date
April 17, 2029
Product Models
Panther Fusion Paraflu Assay Cartridges (PRD-04329), Panther Fusion Paraflu Assay Controls (PRD-04337), Panther Fusion Oil Reagent (PRD-04335), Panther Fusion Elution Buffer (PRD-04334), Panther Fusion Extraction Reagents-S (PRD-04331), Panther Fusion Internal Control-S (PRD-04332), Panther Fusion Reconstitution Buffer I (PRD-04333), Panther Fusion Specimen Lysis Tube (PRD-04339)
Panther Fusion Paraflu 检测试剂盒 (PRD-04329)、Panther Fusion Paraflu 检测试剂盒 (PRD-04337)、Panther Fusion 油试剂 (PRD-04335)、Panther Fusion 洗脱缓冲液 (PRD-04334)、Panther Fusion 提取试剂 -S (PRD-04331)、Panther Fusion 内部对照品 S (PRD-04332)、Panther Fusion 复溶缓冲液 I (PRD-04333)、Panther 融合标本裂解管 (PRD-04339)