Taiwan FDA registration 7fa61e5a95e4776685aa1a33ef26572c
“Vircell” CYTOMEGALOVIRUS VIRCLIA IgM MONOTEST
TW: “凡賽爾”巨細胞病毒化學冷光免疫分析IgM試劑組
Taiwan·Risk Class 2·MD·VIRCELL, S.L·Registered Jan 25, 2019 – Jan 25, 2024ExpiredRegistration details
- Analysis ID
- 7fa61e5a95e4776685aa1a33ef26572c
- License Form
- Ministry of Health Medical Device Import No. 032151
- Customs Code
- DHA05603215102
Company information
- Manufacturer
- VIRCELL, S.L
- Manufacturer Country
- Spain
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- This product is an indirect chemiluminescent immunoassay (CLIA) reagent, combined with Thunderbolt Immunoassay Analyzer, to qualitatively detect anti-cytomegalovirus IgM antibodies in human plasma.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3175 CMV serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jan 25, 2019
- Expiry Date
- Jan 25, 2024
About this record
Access comprehensive regulatory information for “Vircell” CYTOMEGALOVIRUS VIRCLIA IgM MONOTEST in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7fa61e5a95e4776685aa1a33ef26572c and manufactured by VIRCELL, S.L. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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