IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans, Antigen

体外诊断检测试剂/试剂盒、血清学、真菌/酵母、新型隐球菌、抗原

Remel, Inc.·C·Hong Kong MDACS·Registered November 15, 2023

Device overview

Risk class: C
Product code: 19447
State: current
Status: N/A
Product code detail: 19447 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans, Antigen

Manufacturer (製造商)

Name: Remel, Inc.
Remel, Inc
Country: United States
美国
Address: 12076 Santa Fe Trail Drive, Lenexa, Kansas, 66215, USA
12076 Santa Fe Trail Drive, Lenexa, 堪萨斯州, 66215, USA

Authorised representative (AR)

Name: Thermo Fisher Scientific (Hong Kong) Limited
赛默飞世尔科技(香港)有限公司
Phone: 31077600

Regulatory timeline

Registration date: November 15, 2023
Expiry date: November 15, 2028

Product models

Cryptococcus Antigen Latex Test (R30851501)

隐球菌抗原乳胶检测(R30851501)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans, Antigen. 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, Serology, Fungi/Yeast, Cryptococcus neoformans, Antigen

產品資訊： 体外诊断检测试剂/试剂盒、血清学、真菌/酵母、新型隐球菌、抗原