IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe

体外诊断检测试剂/试剂盒、分子检测试剂盒、核酸探针

Hologic, Inc.·D·Hong Kong MDACS·Registered September 24, 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 States
10210遗传中心驱动器, 圣地亚哥, CA 92121, 美

Authorised representative (AR)

Name: Grifols (HK) Limited
Phone: 21613100

Regulatory timeline

Registration date: September 24, 2015
Expiry date: September 24, 2020

Product models

Procleix Ultrio Elite Assay (303330, 303715), Procleix Ultrio Elite HIV, HCV and HBV Discriminatory Probe Reagents (303334), Procleix Ultrio Elite Target Enhancer Reagent (303331, 303722), Procleix Ultrio Elite Negative Calibrators (303333), Procleix Ultrio Elite Positive Calibrators (303332), Procieix Ultrio Elite Assay Calibrators Kit (303719, 303723), Procleix Assay Fluids Kit (303344), Procleix Auto Detect Reagents Kit (303345)

Procleix Ultrio Elite 检测试剂盒 (303330, 303715), Procleix Ultrio Elite HIV、HCV 和 HBV 鉴别探针试剂 (303334), Procleix Ultrio Elite 靶标增强试剂 (303331, 303722), Procleix Ultrio Elite Negative Basencary Basencary (303333), Procleix Ultrio Elite Positive Basec 303332), Procieix Ultrio Elite Agtest Apological 校准试剂盒 (303719, 303723), Procleix 检测液试剂盒 (303344), Procleix 自动检测试剂盒 (303345)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe. 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