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 Diagnostic 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 Diagnostic Solutions Inc.
Grifols Diagnostic Solutions Inc.
Country: United States
美国
Address: 4560 Horton Street, Emeryville, California 94608, USA
4560霍顿街,埃默里维尔,加利福尼亚州94608,美国

Authorised representative (AR)

Name: Grifols (HK) Limited
Phone: 21613100

Regulatory timeline

Registration date: June 14, 2023
Expiry date: August 21, 2028

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 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 Basecover (303333), Procleix Ultrio Elite Positive Basec 303332), Procieix Ultrio Elite Agtest 检测校准品试剂盒 (303719, 303723)

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