140213
D
current
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II, Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใไบบ T ็ป่ๅๆทๅทด็ป่็ ๆฏ-I/IIใๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II, Antibody. 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, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II, Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใไบบ T ็ป่ๅๆทๅทด็ป่็ ๆฏ-I/IIใๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19073
Product Code Detail
19073 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II, Antibody
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Abbott GmbH & Co. KG
Abbott Gmbh
Germany
ๅพทๅฝ
Max-Planck-Ring 2, 65205 Wiesbaden, Germany
้ฉฌๅ
ๆฏ-ๆฎๆๅ
็ฏ 2, 65205 ๅจๆฏๅทด็ป, ๅพทๅฝ
Authorised Representative (AR)
Abbott Laboratories Limited
็พๅฝ้
ๅนๅถ่ฏๆ้ๅ
ฌๅธ
25668711, 98615786
Regulatory Timeline
Registration Date
March 21, 2024
Expiry Date
July 22, 2029
Product Models
ARCHITECT rHTLV-I/II Reagent Kit (6L61-25, 6L61-35, 6L61-30), ARCHITECT rHTLV-I/II Calibrator (6L61-01), ARCHITECT rHTLV-I/II Controls (6L61-10)
ๅปบ็ญๅธ rHTLV-I/II ่ฏๅ็ (6L61-25, 6L61-35, 6L61-30), ๅปบ็ญๅธ RHTLV-I/II ๆ กๅๅจ (6L61-01), ๅปบ็ญๅธ RHTLV-I/II ๅฏน็
ง (6L61-10)