230088
B
current
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin Mไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใๅ ็ซ็่็ฝ M
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M. 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, Immunoglobulin M
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใๅ ็ซ็่็ฝ M
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17373
Product Code Detail
17373 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
PHADIA AB
Phadia Ab
Rapsgatan 7P PO. Box 6460, 751 37 UPPSALA SWEDEN
ๆๆฎๆฏๅ ๅฆ 7P PO.ๆก 6460, 751 37 ไนๆฎ่จๆ็ๅ
ธ
Authorised Representative (AR)
Thermo Fisher Scientific (Hong Kong) Limited
่ต้ป้ฃไธๅฐ็งๆ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
31077600
Regulatory Timeline
Registration Date
August 16, 2024
Expiry Date
March 02, 2028
Product Models
EliA Cardiolipin IgM (14-5530-01), EliA IgM Calibrator Well (14-5527-01),EliA IgM Conjugate 50 (83-1051-01), EliA IgM Conjugate 200 (83-1072-01), EliA IgM Calibrator Strips (83-1052-01), EliA IgM Curve Control Strips (83-1053-01)
EliA ๅฟ็ฃท่ IgM (14-5530-01), EliA IgM ๆ กๅๅๅญ (14-5527-01),EliA IgM ๅถ่็ฉ 50 (83-1051-01), EliA IgM ๅถ่็ฉ 200 (83-1072-01), EliA IgM ๆ กๅๅๆก (83-1052-01), EliA IgM ๆฒ็บฟๅฏน็
งๆก (83-1053-01)