240130
C
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virusไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆใ็ ๆฏ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus. 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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆใ็ ๆฏ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19242
Product Code Detail
19242 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus
State
current
Status
N/A
Brand
Panther Fusion AdV/hMPV/RV Assay
่ฑน่ๅ AdV/hMPV/RV ๆฃๆต
Manufacturer (่ฃฝ้ ๅ)
Hologic Inc.
Hologic
10210 Genetic Center Drive, San Diego, California 92121 UNITED STATES
10210้ไผ ไธญๅฟ้ฉฑๅจๅจ, ๅฃๅฐไบๅฅ, ๅ ๅฉ็ฆๅฐผไบๅท 92121 ็พๅฝ
Authorised Representative (AR)
Hologic Asia Pacific Limited
็พๅฝ่ฑชๆดๆทไบๅคชๆ้ๅ
ฌๅธ
37487700
Regulatory Timeline
Registration Date
April 18, 2024
Expiry Date
April 17, 2029
Product Models
Panther Fusion AdV/hMPV/RV Assay Cartridges (PRD-04330), Panther Fusion AdV/hMPV/RV Assay Controls (PRD-04338), Panther Fusion Oil Reagent (PRD-04335), Panther Fusion Elution Buffer (PRD-04334), Panther Fusion Extraction reagent-S (PRD-04331), Panther Fusion Internal Control-S (PRD-04332), Panther Fusion Reconstitution Buffer I (PRD-04333), Panther Fusion Specimen Lysis Tubes (PRD-04339)
Panther Fusion AdV/hMPV/RV ๆฃๆต็ (PRD-04330)ใPanther Fusion AdV/hMPV/RV ๆฃๆตๅฏน็
งๅ (PRD-04338)ใPanther Fusion ๆฒน่ฏๅ (PRD-04335)ใPanther Fusion ๆด่ฑ็ผๅฒๆถฒ (PRD-04334)ใPanther Fusion ๆๅ่ฏๅ S (PRD-04331)ใPanther Fusion ๅ
ๆงๅ S (PRD-04332)ใPanther ่ๅๅคๆบถ็ผๅฒๆถฒ I (PRD-04333)ใPanther ่ๅ่ฏๆ ท่ฃ่งฃ็ฎก (PRD-04339)