Taiwan FDA registration 49c844fc8e0a564d6da5e1d4b407f0cc
Reek Shang bone salty phosphatase detection reagent
TW: 禮雅尚骨質鹹性磷酸酶檢測試劑
Taiwan·Risk Class 2·DIASORIN INC.·Registered Jun 15, 2022 – Jun 15, 2027ActiveRegistration details
- Analysis ID
- 49c844fc8e0a564d6da5e1d4b407f0cc
- Customs Code
- DHA05603565506
Company information
- Manufacturer
- DIASORIN INC.
- Manufacturer Country
- United States
- Authorized Representative
- MEDRICH INSTRUMENT CO., LTD.
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1050 Chromic phosphatase or isoenzyme test system
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jun 15, 2022
- Expiry Date
- Jun 15, 2027
About this record
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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