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Reek Shang bone salty phosphatase detection reagent - Taiwan Registration 49c844fc8e0a564d6da5e1d4b407f0cc

Access comprehensive regulatory information for Reek Shang bone salty phosphatase detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 49c844fc8e0a564d6da5e1d4b407f0cc and manufactured by DIASORIN INC.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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49c844fc8e0a564d6da5e1d4b407f0cc
Registration Details
Taiwan FDA Registration: 49c844fc8e0a564d6da5e1d4b407f0cc
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Device Details

Reek Shang bone salty phosphatase detection reagent
TW: ็ฆฎ้›…ๅฐš้ชจ่ณช้นนๆ€ง็ฃท้…ธ้…ถๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

49c844fc8e0a564d6da5e1d4b407f0cc

DHA05603565506

Company Information

United States

Product Details

This product is a one-step delayed addition of sandwich chemifluorescence immunoassay (CLIA) to quantitatively determine bone salty phosphatase (BAP) in human serum. This test must be performed on the Regal Senson Series analyzers.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); A.1050 Chromic phosphatase or isoenzyme test system

Input;; QMS/QSD

Dates and Status

Jun 15, 2022

Jun 15, 2027