230086
B
current
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin Aไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใๅ ็ซ็่็ฝA
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A. 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 A
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่็ฝ่ดจใๅ ็ซ็่็ฝA
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17369
Product Code Detail
17369 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A
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 IgA (14-5528-01), EliA IgA Calibrator Well (14-5516-01), EliA Dummy Well (14-5510-01), EliA IgG/IgM/IgA Negative Control 200 (83-1157-01), EliA Sample Diluent (83-1144-01), EliA IgA Conjugate 50 (83-1021-01), EliA IgA Conjugate 200 (83-1022-01), EliA IgA Calibrator Strips (83-1019-01), EliA IgA Curve Control Strips (83-1020-01), EliA APS Positive Control 250 (83-1055-01), EliA IgG/IgM/IgA Negative Control 250 (83-1037-01), EliA Sample Diluent (83-1023-01)
EliA ๅฟ็ฃท่ IgA (14-5528-01)ใEliA IgA ๆ กๅๅญ (14-5516-01)ใEliA ่ๆๅญ (14-5510-01)ใEliA IgG/IgM/IgA ้ดๆงๅฏน็
ง 200 (83-1157-01)ใEliA ๆ ทๅ็จ้ๅ (83-1144-01)ใEliA IgA ๅถ่็ฉ 50 (83-10202) 1-01)ใEliA IgA ๅถ่็ฉ 200 (83-1022-01)ใEliA IgA ๆ กๅๅๆก (83-1019-01)ใEliA IgA ๆฒ็บฟๅฏน็
งๆก (83-1020-01)ใEliA APS ้ณๆงๅฏน็
งๅ 250 (83-1055-01)ใEliA IgG/IgM/IgA ้ดๆงๅฏน็
งๅ 250 (83-1037-01)ใ EliA ๆ ทๅ็จ้ๅ (83-1023-01)