241106
C
current
IVD Test Reagent/Kits, Microbiology, Virus, Identification, Herpes Simplexไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅพฎ็็ฉๅญฆ, ็ ๆฏ, ้ดๅฎ, ๅ็บฏ็ฑ็น็ ๆฏ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Microbiology, Virus, Identification, Herpes Simplex. 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, Microbiology, Virus, Identification, Herpes Simplex
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅพฎ็็ฉๅญฆ, ็ ๆฏ, ้ดๅฎ, ๅ็บฏ็ฑ็น็ ๆฏ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
17362
Product Code Detail
17362 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Herpes Simplex
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Germany
ๅพทๅฝ
Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 ๆผๆตทๅง, ๅพทๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 16, 2024
Expiry Date
October 15, 2029
Product Models
Elecsys HSV-2 IgG (08948909190), Elecsys HSV-2 IgG (08948887190), Elecsys HSV-1 IgG (08948852190), Elecsys HSV-1 IgG (08948844190), PreciControl HSV (05572207190)
Elecsys HSV-2 IgG (08948909190)ใElecsys HSV-2 IgG (08948887190)ใElecsys HSV-1 IgG (08948852190)ใElecsys HSV-1 IgG (08948844190)ใPreciControl HSV (05572207190)