180523
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
Grifols Diagnostics Solutions Inc.·D·Hong Kong MDACS·Registered June 14, 2023
Device overview
- Risk class
- D
- Product code
- 19666
- State
- current
- Status
- N/A
- Product code detail
- 19666 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
Manufacturer (製造商)
- Name
- Grifols Diagnostics Solutions Inc.Grifols Diagnostics Solutions Inc.
- Country
- United States美国
- Address
- 4560 Horton Street, Emeryville, California 94608, United States4560 Horton Street, 埃默里维尔, 加利福尼亚州 94608, 美
Authorised representative (AR)
- Phone
- 21613100
Regulatory timeline
- Registration date
- June 14, 2023
- Expiry date
- December 06, 2028
Product models
Procleix Ultrio Plus Assay 1000/5000 Test Kit (302573, 302574), Procleix Ultrio Plus Assay Calibrators (302575), Procleix Ultrio Plus HBV Discriminatory Probe (302576), Procleix Ultrio Plus HCV Discriminatory Probe (302577), Procleix Ultrio Plus HIV-1 Discriminatory Probe (302571), Procleix Ultrio Plus Tigris Controls Kit (302572), Procleix Ultrio Plus Negative Calibrator Kit (303260), Procleix Ultrio Plus Tigris Negative Controls Kit (303261), Procleix Ultrio Plus HIV-1/HCV/HBV Discriminatory Probe Reagent Kit (PRD-03709), Procleix Wash Solution Kit (303665), Procleix Oil Kit (302441), Procleix Buffer for Deactivation Fluid Kit (303666), Procleix Auto Detect Reagents Kit (301120), Procleix System Fluid Preservative (301175)
Procleix Ultrio Plus 检测 1000/5000 检测试剂盒 (302573, 302574), Procleix Ultrio Plus 检测校准品 (302575), Procleix Ultrio Plus HBV 判别探针 (302576), Procleix Ultrio Plus HCV 判别探针 (302577), Procleix Ultrio Plus HIV-1 判别探针 (302571), Procleix Ultrio Plus 底格里斯对照试剂盒 (302572), Procleix Ultrio Plus 阴性校准试剂盒 (303260), Procleix Ultrio Plus 底格里斯阴性对照试剂盒 (303261), Procleix Ultrio Plus HIV-1/HCV/HBV 鉴别探针试剂盒 (PRD-03709)、Procleix 洗涤液试剂盒 (303665)、Procleix 油试剂盒 (302441)、用于失活液的 Procleix 缓冲液试剂盒 (303666)、Procleix 自动检测试剂盒 (301120)、Procleix 系统流体防腐剂 (301175)
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