110411
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replication
体外诊断 检测试剂/试剂盒、分子检测、核酸处理、复制
Hologic, Inc.·D·Hong Kong MDACS·Registered August 05, 2015
Device overview
- Risk class
- D
- Product code
- 19666
- State
- Expired.
- Status
- N/A
- Product code detail
- 19666 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
Manufacturer (製造商)
- Name
- Hologic, Inc.Hologic
- Country
- United States美国
- Address
- 10210 Genetic Center Drive, San Diego, CA 92121, United States10210遗传中心驱动器, 圣地亚哥, CA 92121, 美
Authorised representative (AR)
- Phone
- 21613100
Regulatory timeline
- Registration date
- August 05, 2015
- Expiry date
- November 18, 2016
Product models
Procleix Ultrio Assay (1000-Test Kit) (301103), Procleix Ultrio Assay (5000-Test Kit) (301105), Procleix Ultrio Assay Calibrators (301106), Procleix Ultrio HBV Discriminatory Probe (301109), Procleix Ultrio HCV Discriminatory Probe (301108), Procleix Ultrio HIV-1 Discriminatory Probe (301107), Procleix Ultrio Tigris Controls (302193), Procleix Ultrio Negative Calibrator Kit (303259), Procleix Ultrio Tigris Negative Controls Kit (303258), Procleix Auto Detect Reagents Kit (301120), Procleix Oil Kit (302441), Procleix Wash Solution (303665), Procleix Buffer for Deactivation Fluid (303666)
Procleix Ultrio 检测试剂盒 (1000-检测试剂盒) (301103), Procleix Ultrio 检测试剂盒 (5000-检测试剂盒) (301105), Procleix Ultrio 检测校准品 (301106), Procleix Ultrio HBV 判别探针 (301109), Procleix Ultrio HCV 判别探针 (301108), Procleix Ultrio HIV-1 判别探针 (301107), Procleix Ultrio 底格里斯对照 (302193), Procleix Ultrio 阴性校准试剂盒 (303259), Procleix Ultrio 底格里斯阴性对照试剂盒 (303258), Procleix 自动检测试剂盒 (301120), Procleix 油套件 (302441), Procleix 洗涤液 (303665), 用于停用液的 Procleix 缓冲液 (303666)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replication. 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, Nucleic Acid Probe
產品資訊： 体外诊断 检测试剂/试剂盒、分子检测试剂盒、核酸探针