Taiwan FDA registration 09796029ec92072db99088a8184e5e81

Reich tissue transglutaminase immunoglobulin A antibody detection reagent

TW: 禮亞尚組織轉谷氨酰胺酶免疫球蛋白A抗體檢測試劑

Taiwan·Risk Class 2·DIASORIN ITALIA S.P.A.·Registered Jan 30, 2013 – Jan 30, 2028Active

Registration details

Analysis ID: 09796029ec92072db99088a8184e5e81
Customs Code: DHA00602472000

Company information

Manufacturer: DIASORIN ITALIA S.P.A.
Manufacturer Country: Italy
Authorized Representative: EVERLIGHT BIOTECH(TAIWAN) CO., LTD.

Product details

Intended Use: Reich Transglutaminase Immunoglobulin A Antibody Assay is a quantitative determination of transglutaminase immunoglobulin A antibody content in human tissue in human serum or plasma using chemical cold light immunoassay (CLIA) technology. The concentration of immunoglobulin A antibodies in transglutaminase, along with other laboratory tests and clinical findings, may be useful in the diagnosis and monitoring of celiac disease (gluten-sensitive intestinal lesions). The experiment must be performed using a Reasan analyzer.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5660 多發性自體抗體免疫試驗系統
Import Information: import

Dates and status

Registration Date: Jan 30, 2013
Expiry Date: Jan 30, 2028

About this record

Access comprehensive regulatory information for Reich tissue transglutaminase immunoglobulin A antibody 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 09796029ec92072db99088a8184e5e81 and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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