210398
B
current
IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitoninไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใ้้็ด ๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin. 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, Protein, Procalcitonin
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใ้้็ด ๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
25106
Product Code Detail
25106 IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Immunotech SAS, A Beckman Coulter Company
Beckman Coulter, Inc.
France
ๆณๅฝ
130 Avenue de Lattre de Tassigny, BP 177, Marseille, Cedex 9, 13276, France
130 Avenue de Lattre de Tassigny, BP 177, ้ฉฌ่ต, Cedex 9, 13276, ๆณๅฝ
Authorised Representative (AR)
Beckman Coulter Hong Kong Limited
่ดๅ
ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ
ฌๅธ
28147431
Regulatory Timeline
Registration Date
July 24, 2024
Expiry Date
December 03, 2026
Product Models
Access PCT (Reagent Pack) (C22593), Access PCT (Calibrators) (C22594)
Access PCT(่ฏๅๅ
) (C22593)ใAccess PCT(ๆ กๅๅ) (C22594)