240341
B
current
IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobinไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใๅฟ่ๆ ๅฟ็ฉใ่็ฝ่ดจใ่็บข่็ฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin. 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, Cardiac Marker, Protein, Myoglobin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใๅฟ่ๆ ๅฟ็ฉใ่็ฝ่ดจใ่็บข่็ฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17314
Product Code Detail
17314 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin
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 Myoglobin (Reagent Pack) (973243), Access Myoglobin (Calibrators) (973244)
Access Myoglobin(่ฏๅๅ
)(973243),Access Myoglobin(ๆ กๅๅ)(973244)