240422
B
current
IVD Test Reagent/Kits, Immunoassay, Endocrine, Insulin-Like Growth Factor Binding Protein 3ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ๅ ๅๆณ, ่ฐๅฒ็ด ๆ ท็้ฟๅ ๅญ็ปๅ่็ฝ 3
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Endocrine, Insulin-Like Growth Factor Binding Protein 3. 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, Immunoassay, Endocrine, Insulin-Like Growth Factor Binding Protein 3
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ๅ ๅๆณ, ่ฐๅฒ็ด ๆ ท็้ฟๅ ๅญ็ปๅ่็ฝ 3
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19917
Product Code Detail
19917 IVD Test Reagent/Kits, Immunoassay, Endocrine, Insulin-Like Growth Factor Binding Protein 3
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
September 24, 2024
Expiry Date
September 23, 2029
Product Models
Elecsys IGFBP-3 (07574690190, 07574720190), CalSet IGFBP-3 (07574762190)
Elecsys IGFBP-3 (07574690190, 07574720190), CalSet IGFBP-3 (07574762190)