240336
C
current
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ฟ็คๆ ๅฟ็ฉใ็ขณๆฐดๅๅ็ฉๆๅ CA 125
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125. 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, Tumor Marker, Carbohydrate Antigen CA 125
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ฟ็คๆ ๅฟ็ฉใ็ขณๆฐดๅๅ็ฉๆๅ CA 125
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19104
Product Code Detail
19104 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Beckman Coulter, Inc.
Beckman Coulter, Inc.
United States
็พๅฝ
250 South Kraemer Blvd., Brea, California, 92821, USA
250ๅๅ
้ท้ปๅคง้,ๅธ้ทไบ,ๅ ๅฉ็ฆๅฐผไบๅท,92821,็พๅฝ
Authorised Representative (AR)
Beckman Coulter Hong Kong Limited
่ดๅ
ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ
ฌๅธ
28147431
Regulatory Timeline
Registration Date
August 08, 2024
Expiry Date
August 07, 2029
Product Models
Access OV Monitor (Reagent Pack) (386357), Access OV Monitor (Calibrators) (386358)
Access OV ็่งๅจ(่ฏๅๅ
) (386357), Access OV ็่งๅจ(ๆ กๅๅจ) (386358)