Taiwan FDA registration 5c88e0b3d1ed2191f91b542b3671d082

Reich 1-84 pairs of thyroxine test reagents

TW: 禮雅尚 1-84副甲狀腺素檢驗試劑

Taiwan·Risk Class 2·DIASORIN INC.·Registered Nov 11, 2020 – Nov 11, 2025Expired

Registration details

Analysis ID: 5c88e0b3d1ed2191f91b542b3671d082
Customs Code: DHA05603415609

Company information

Manufacturer: DIASORIN INC.
Manufacturer Country: United States
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: THIS PRODUCT USES CHEMICAL COLD LIGHT IMMUNOASSAY (CLIA) TECHNOLOGY TO QUANTITATIVELY DETERMINE 1-84 PARATHYROXINE WITHOUT CROSS-REACTIVITY OF 7-84* PARATHYROXINE FRAGMENTS IN SERUM AND ETHYLENEDIAMINETETRAACETIC ACID-CONTAINING PLASMA SAMPLES ON LIAISON AND LIAISON XL ANALYZERS. Parathyroxine concentration can be used to differentiate between hypercalcemia and hypocalcemia caused by abnormal phosphorus and calcium metabolism.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); A.1545 Parathyroid hormone test system
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Nov 11, 2020
Expiry Date: Nov 11, 2025

About this record

Access comprehensive regulatory information for Reich 1-84 pairs of thyroxine test reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5c88e0b3d1ed2191f91b542b3671d082 and manufactured by DIASORIN INC.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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