Taiwan FDA registration 77266c214aff188e35c6aaafce30cd9b

Reapan CMV immunoglobulin G affinity detection reagent

TW: 禮亞尚巨細胞病毒免疫球蛋白G親和性檢測試劑

Taiwan·Risk Class 2·DIASORIN ITALIA S.P.A.·Registered Oct 01, 2013 – Oct 01, 2028Active

Registration details

Analysis ID: 77266c214aff188e35c6aaafce30cd9b
Customs Code: DHA05602529904

Company information

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

Product details

Intended Use: This in vitro assay is used to measure the affinity of human serum and plasma for cytomegalovirus IgG antibodies using chemical cold light particle immunoassay (CLIA). The experiment must be performed using a Reasan analyzer.
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.3175 Cytomegalovirus serum test
Import Information: import

Dates and status

Registration Date: Oct 01, 2013
Expiry Date: Oct 01, 2028

About this record

Access comprehensive regulatory information for Reapan CMV immunoglobulin G affinity 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 77266c214aff188e35c6aaafce30cd9b and manufactured by DIASORIN ITALIA S.P.A.. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..

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