Taiwan FDA registration f1810b182133720f858767014354e777

Reek Shang Thyroglobulin Second Generation Detection Reagent

TW: 禮雅尚甲狀腺球蛋白第二代檢測試劑

Taiwan·Risk Class 2·DIASORIN ITALIA S.P.A.·Registered Aug 25, 2021 – Aug 25, 2026Active

Registration details

Analysis ID: f1810b182133720f858767014354e777
Customs Code: DHA05603489600

Company information

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

Product details

Intended Use: LIAISON Tg II Gen: This product is used with a Chemical Cold Light Immunoassay (CLIA) analyzer to quantitatively detect human thyroglobulin (Tg) in human serum or plasma (heparin, ethylenediaminetetraacetic acid, citrate) samples. LIAISON Control Tg II Gen: This product is used in Chemical Cold Light Immunoassay (CLIA), a second generation assay for Thyroglobulin at Reich Thyroglobulin, to verify test confidence. LIAISON Tg II Gen Confirmatory: This product is an external neutralization test used in conjunction with Reisan Thyroglobulin II Detection Reagent (Model 317220) to assist in confirming thyroglobulin results and assessing potential effects.
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); C.6010 Tumor-associated antigen immunoassay system
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Aug 25, 2021
Expiry Date: Aug 25, 2026

About this record

Access comprehensive regulatory information for Reek Shang Thyroglobulin Second Generation 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 f1810b182133720f858767014354e777 and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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