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Vites precalcitonin immunoassay reagent set - Taiwan Registration 8fb2016f42555a8cec33b3f9f82b1e80

Access comprehensive regulatory information for Vites precalcitonin immunoassay reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8fb2016f42555a8cec33b3f9f82b1e80 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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8fb2016f42555a8cec33b3f9f82b1e80
Registration Details
Taiwan FDA Registration: 8fb2016f42555a8cec33b3f9f82b1e80
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Device Details

Vites precalcitonin immunoassay reagent set
TW: ็ถญ็‰นๅธๅ‰้™้ˆฃ็ด ๅ…็–ซๆชขๆธฌ่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

8fb2016f42555a8cec33b3f9f82b1e80

DHA05603750803

Company Information

United Kingdom

Product Details

็”จๆ–ผ VITROS ECi/ECiQ/3600 ๅ…็–ซ่จบๆ–ทๅˆ†ๆžๅ„€ๅ’Œ VITROS 5600/XT 7600 ๅ…จ่‡ชๅ‹•็”ŸๅŒ–ๅ…็–ซๅˆ†ๆžๅ„€ๅฎš้‡ๆธฌๅฎšไบบ่ก€ๆธ…ๅ’Œ่ก€ๆผฟ (่‚็ด ้‹ฐๅ’Œ EDTA) ไธญ็š„ๅ‰้™้ˆฃ็ด  (PCT).

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

C.3210 Endotoxin Analysis Test;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Oct 28, 2024

Oct 28, 2029