240378
C
current
IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecificไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซ่กๆถฒๅญฆ, ๆไฝๆฃๆต/้ดๅฎ, ๆไบบ็่็ฝ, ๅค็นๅผๆง
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecific. 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, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecific
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซ่กๆถฒๅญฆ, ๆไฝๆฃๆต/้ดๅฎ, ๆไบบ็่็ฝ, ๅค็นๅผๆง
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19780
Product Code Detail
19780 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecific
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Bio-Rad Medical Diagnostics GmbH
Bio-Rad Medical Diagnostics GmbH
Germany
ๅพทๅฝ
Industriestr. 1, 63303 Dreieich, Germany
ๅทฅไธ1, 63303 Dreieich, ๅพทๅฝ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
September 11, 2024
Expiry Date
September 10, 2029
Product Models
Anti-Human-Globulin (804020), Anti-Human-Globulin Color (804115, 804120, 804130)
ๆไบบ็่็ฝ (804020)ใๆไบบ็่็ฝ้ข่ฒ (804115, 804120, 804130)