190271
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Zika
体外诊断 检测试剂/试剂盒、分子检测、感染、病毒、寨卡病毒
Grifols Diagnostic Solutions Inc.·D·Hong Kong MDACS·Registered August 16, 2024
Device overview
- Risk class
- D
- Product code
- 37128
- State
- current
- Status
- N/A
- Product code detail
- 37128 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Zika
Manufacturer (製造商)
- Name
- Grifols Diagnostic Solutions Inc.Grifols Diagnostic Solutions Inc.
- Country
- United States美国
- Address
- 4560 Horton Street, Emeryville, CA 94608, USA4560霍顿街,埃默里维尔,CA 94608,美国
Authorised representative (AR)
- Phone
- 21613100
Regulatory timeline
- Registration date
- August 16, 2024
- Expiry date
- September 02, 2029
Product models
Procleix Zika Virus Assay Kit (PRD-04170, PRD-04228), Procleix Zika Virus Assay Calibrators Kit (PRD-04171, PRD-04229), Procleix Assay Fluids Kit (303344), Procleix Auto Detect Reagents Kit (303345)
Procleix 寨卡病毒检测试剂盒 (PRD-04170, PRD-04228), Procleix 寨卡病毒检测校准试剂盒 (PRD-04171, PRD-04229), 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, Infection, Virus, Zika. 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, Zika
產品資訊： 体外诊断 检测试剂/试剂盒、分子检测、感染、病毒、寨卡病毒