Pure Global
240369
B
current

IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisolไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่‚พ่„ไปฃ่ฐขใ€็šฎ่ดจ้†‡

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol. 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, Renal Metabolism, Cortisol

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่‚พ่„ไปฃ่ฐขใ€็šฎ่ดจ้†‡

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19131
Product Code Detail
19131 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
United States
็พŽๅ›ฝ
511 Benedict Ave, Tarrytown NY 10591, USA
511ๆœฌๅฐผ่ฟชๅ…‹็‰นๅคง้“,็บฝ็บฆๅก”้‡Œๆ•ฆ10591,็พŽๅ›ฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้—จๅญๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
25833388
Regulatory Timeline
Registration Date
September 11, 2024
Expiry Date
September 10, 2029
Product Models
Atellica IM Cortisol (Cor) (10995537, 10995538), Atellica IM Calibrator E (CAL E) (10995512, 10995513), Atellica IM Cortisol Urine Reconstitution Buffer (10995540)
Atellica IM ็šฎ่ดจ้†‡ (COR) (10995537, 10995538), Atellica IM ๆ กๅ‡†ๅ™จ E (CAL E) (10995512, 10995513), Atellica IM ็šฎ่ดจ้†‡ๅฐฟๆถฒ้‡ๅปบ็ผ“ๅ†ฒๆถฒ (10995540)