Taiwan FDA registration 14173d9b16d0e4fba1c21b14ccf0385b

Regal Chambrams procalcitonin test second generation reagent set

TW: 禮雅尚布拉姆斯前降鈣素檢驗二代試劑組

Taiwan·Risk Class 2·DIASORIN ITALIA S.P.A.·Registered Jan 19, 2018 – Jan 19, 2028Active

Registration details

Analysis ID: 14173d9b16d0e4fba1c21b14ccf0385b
Customs Code: DHA05603048600

Company information

Manufacturer: DIASORIN ITALIA S.P.A.
Manufacturer Country: Italy
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: This product is used for the quantitative detection of procalcitonin in human serum and plasma samples by chemical cold light immunoassay (CLIA) in vitro. Experiments must be performed using the Reich Series analyzers.
Product Type (Level 1): C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
Product Type (Level 2): C.3210 Endotoxin Analysis Test;; A.1660 Quality control materials (analytical and non-analytical)
Import Information: import

Dates and status

Registration Date: Jan 19, 2018
Expiry Date: Jan 19, 2028

About this record

Access comprehensive regulatory information for Regal Chambrams procalcitonin test second generation 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 14173d9b16d0e4fba1c21b14ccf0385b and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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