Pure Global
200378
C
current

IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigenไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่‚ฟ็˜คๆ ‡ๅฟ—็‰ฉใ€้…ถใ€ๅ‰ๅˆ—่…บ็‰นๅผ‚ๆ€งๆŠ—ๅŽŸ

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen. 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, Tumor Marker, Enzyme, Prostate Specific Antigen

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่‚ฟ็˜คๆ ‡ๅฟ—็‰ฉใ€้…ถใ€ๅ‰ๅˆ—่…บ็‰นๅผ‚ๆ€งๆŠ—ๅŽŸ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
18127
Product Code Detail
18127 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Beckman Coulter, Inc.
Beckman Coulter, Inc.
United States
็พŽๅ›ฝ
250 South Kraemer Blvd., Brea, California, 92821, USA
250ๅ—ๅ…‹้›ท้ป˜ๅคง้“,ๅธƒ้›ทไบš,ๅŠ ๅˆฉ็ฆๅฐผไบšๅทž,92821,็พŽๅ›ฝ
Authorised Representative (AR)
Beckman Coulter Hong Kong Limited
่ดๅ…‹ๆ›ผๅบ“ๅฐ”็‰น้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
28147431
Regulatory Timeline
Registration Date
August 08, 2024
Expiry Date
November 18, 2025
Product Models
Access Hybritech p2PSA (Reagent Pack) (A49752), Access Hybritech p2PSA (Calibrators) (A49753), Access Hybritech p2PSA (QC) (A56934), Access Hybritech PSA (Reagent Pack) (37200), Access Hybritech PSA (Calibrators) (37205), Access Hybritech PSA (QC) (37209), Access Hybritech PSA (Diluent) (37206), Access Hybritech PSA (Falcon 2x100) (C22845), Access Hybritech free PSA (Reagent Pack) (37210, C22846), Access Hybritech free PSA (Calibrators) (37215), Access Hybritech free PSA (QC) (37219)
Access Hybritech p2PSA(่ฏ•ๅ‰‚ๅŒ…) (A49752), Access Hybritech p2PSA (ๆ กๅ‡†ๅ“) (A49753), Access Hybritech p2PSA (QC) (A56934), Access Hybritech PSA (่ฏ•ๅ‰‚ๅŒ…) (37200), Access Hybritech PSA (ๆ กๅ‡†ๅ“) (37205), Access Hybritech PSA (QC) (37209), Access Hybritech PSA (็จ€้‡Šๅ‰‚) (37206), Access Hybritech PSA (Falcon 2x100) (C22845), Access Hybritech free PSA(่ฏ•ๅ‰‚ๅŒ…) (37210, C22846), Access Hybritech free PSA (ๆ กๅ‡†ๅ™จ) (37215), ่ฎฟ้—ฎ Hybritech ๅ…่ดน PSA (QC) (37219)